FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91057–91080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1998
ROSS ENTERAL FEEDING TUBE
K972437 · FPD
Ross Products
Gastroenterology & Urology · 210d
Cleared Jan 26, 1998
PERIO CONTROL II
K972642 · EIK
Estrad B.V.
Dental · 195d
Cleared Jan 26, 1998
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
K973875 · KMA
Respironics, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 26, 1998
PYRILINKS-D ASSAY KIT
K974260 · JMM
Metra Biosystems, Inc.
Chemistry · 74d
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451 · CGA
Lifescan, Inc.
Chemistry · 62d
Cleared Jan 26, 1998
QUICKSTICK PRO HCG TEST
K974615 · JHI
Phamatech
Chemistry · 46d
Cleared Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · LBR
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · LCX
Quidel Corp.
Chemistry · 34d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · DSP
Arrow Intl., Inc.
Cardiovascular · 392d
Cleared Jan 23, 1998
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
K970866 · HIF
Georgia Biomedical, Inc.
Obstetrics & Gynecology · 319d
Cleared Jan 23, 1998
HYDROBRUSH (TM) KERATOME
K971078 · HQS
Medjet, Inc.
Ophthalmic · 305d
Cleared Jan 23, 1998
MCKINLEY OUTBOUND-2 SYSTEM
K971844 · FPA
Mckinley, Inc.
General Hospital · 249d
Cleared Jan 23, 1998
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972025 · KNT
Radius Intl., Inc.
Gastroenterology & Urology · 235d
Cleared Jan 23, 1998
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972102 · KNT
Radius Intl., Inc.
Gastroenterology & Urology · 233d
Cleared Jan 23, 1998
ORATEC MODEL ENDOTAC PROBE
K972358 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 212d
Cleared Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722 · HWC
Orthopedic Designs, Inc.
Orthopedic · 186d
Cleared Jan 23, 1998
ADVANCED TREATMENT PLANNING SYSTEM
K972816 · IYE
Advanced Radiation Therapy Systems, Inc.
Radiology · 178d
Cleared Jan 23, 1998
WOUND DRAINAGE HOLDER
K973183 · KGZ
R & D Medical Products, Inc.
General & Plastic Surgery · 151d
Cleared Jan 23, 1998
EXMOOR TYMPANOCENTESIS KIT (TK/1)
K973587 · JZF
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 123d
Cleared Jan 23, 1998
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24...
K973713 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 116d
Cleared Jan 23, 1998
MEGAPULSE II
K973732 · IMJ
Pti
Physical Medicine · 115d
Cleared Jan 23, 1998
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K974118 · IWJ
Worldwide Medical Technologies, LLC
Radiology · 84d
Cleared Jan 23, 1998
PROCERA PREPARABLE ABUTMENT SYSTEM
K974150 · NHA
Nobel Biocare Uas, Inc.
Dental · 80d
Cleared Jan 23, 1998
COOPERSURGICAL INFRARED COAGULATOR
K974168 · KNS
Hogan & Hartson
Gastroenterology & Urology · 79d