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
88945–88968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1998
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
K980588 · GAD
Clarus Medical Systems, Inc.
General & Plastic Surgery · 182d
Cleared Aug 18, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 160d
Cleared Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 18, 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846 · GWM
Camino Neurocare, Inc.
Neurology · 84d
Cleared Aug 18, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
K981854 · JIT
Olympus Diagnostica GmbH
Chemistry · 84d
Cleared Aug 18, 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · JEY
Synthes (Usa)
Dental · 81d
Cleared Aug 18, 1998
QUICK & SURE ONESTEP HOME PREGNANCY TEST
K981892 · LCX
Abacus Diagnostics
Chemistry · 81d
Cleared Aug 18, 1998
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO....
K981905 · FOZ
Acu-Pak
General Hospital · 78d
Cleared Aug 18, 1998
APOLLO 95E
K981948 · EBF
Dental/Medical Diagnostic Systems, Inc.
Dental · 76d
Cleared Aug 18, 1998
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K981953 · HEB
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 76d
Cleared Aug 18, 1998
CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
K981962 · FSS
Cuda Products Co.
General & Plastic Surgery · 75d
Cleared Aug 18, 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004 · JAK
General Electric Co.
Radiology · 71d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087 · DCK
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Aug 18, 1998
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
K982251 · CDO
Sigma Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 18, 1998
MB/BACT BLOOD CULTURE BOTTLE
K982263 · MDB
Organon Teknika Corp.
Microbiology · 50d
Cleared Aug 18, 1998
DPX-RX BONE DENSITOMETER
K982267 · KGI
Lunar Corp.
Radiology · 50d
Cleared Aug 18, 1998
INFRAMETRICS INFRACAM-MED
K982327 · LHQ
Inframetrics, Inc.
Radiology · 47d
Cleared Aug 18, 1998
OPC LOWWEAR PORCELAIN
K982377 · EIH
Jeneric/Pentron, Inc.
Dental · 41d
Cleared Aug 18, 1998
DYTRACT FLOW RESTORATIVE
K982395 · EBF
Dentsply Intl.
Dental · 40d
Cleared Aug 18, 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE...
K982551 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Aug 18, 1998
ENVOY AND VISTA BRITE TIP
K982632 · DQY
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 18, 1998
6F ENVOY GUIDING CATHETER
K982770 · DQY
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 17, 1998
A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
K971434 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 486d
Cleared Aug 17, 1998
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · DZE
Implant Innovations, Inc.
Dental · 220d