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High RiskFDA
Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to ...
Medical Implants·7 affected·Mar 9, 2015
High RiskFDA
Bacterin International, Inc.
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in th...
Medical Devices·63 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x10mm, Article No. 36711.
Medical Devices·636 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Medical Devices·679 affected·Mar 9, 2015
High RiskFDA
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to...
Medical Implants·17 affected·Mar 9, 2015
High RiskFDA
In2bones, Sas
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Medical Implants·15 affected·Mar 9, 2015
High RiskFDA
James G. Cole, Inc., Dba Asn/maxam Neutraceutics
ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label. *********the List of ASN products********...
Food·0 affected·Mar 6, 2015
High RiskFDA
Cost Plus Management Services, Inc.
Shanghai Ceramic Spoons; SKU 487874; UPC 2487874
Food·15,700 affected·Mar 6, 2015
High RiskFDA
Interbake Foods Llc
Mrs. Fields White Chunk Macadamia Cookies; 12 individually wrapped cookies in a tray/box; there are 6 trays/boxes to a case. Therefore th...
Bakery & Grains·16,877 affected·Mar 6, 2015
High RiskFDA
Polar Corp.
Stop & Shop Clear Splash Orange Mango, 1 liter plastic bottle Flavored Sparkling Water Beverage Distributed by Foodhold U.S.A., LLC La...
Beverages·6,096 affected·Mar 6, 2015
High RiskFDA
James G. Cole, Inc., Dba Asn/maxam Neutraceutics
ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label. ********The List of MAXAM products****...
Supplements·0 affected·Mar 6, 2015
High RiskFDA
Fusion Pharmaceuticals, Llc
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768...
Oral Drugs·9,439 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·125 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
Medical Devices·167 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·11 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
Medical Devices·102 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging...
Diagnostic Devices·71 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·10 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
Medical Devices·172 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
Medical Devices·138 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
Medical Devices·301 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
Medical Devices·52 affected·Mar 6, 2015
High RiskFDA
Brainlab Ag
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for st...
Medical Devices·25 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·39 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
Medical Devices·100 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·9 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging...
Diagnostic Devices·25 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
Medical Devices·372 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·23 affected·Mar 6, 2015
High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Diagnostic Devices·72 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
Medical Devices·92 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·215 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·350 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·15 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·10 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic...
Diagnostic Devices·31 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·277 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·156 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·36 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
Medical Devices·102 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic I...
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·7 affected·Mar 6, 2015
High RiskFDA
Nidek Inc
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by m...
Medical Devices·799 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·376 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic ...
Diagnostic Devices·126 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·337 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·3 affected·Mar 6, 2015