FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
88441–88464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792 · FPA
Baxter Healthcare Corp
General Hospital · 88d
Cleared Aug 14, 1998
GB-1002 TENS WITH MASSAGE
K964437 · GZJ
Skylark Device Co., Ltd.
Neurology · 647d
Cleared Aug 14, 1998
DISCAM DIGITAL IMAGING SYSTEM
K974535 · HKI
Marcher Enterprises, Ltd.
Ophthalmic · 255d
Cleared Aug 14, 1998
ASTHMA MONITOR AM2
K980876 · BZG
Erich Jaeger GmbH & Co. KG
Anesthesiology · 161d
Cleared Aug 14, 1998
FLAPMAKER DISPOSABLE MICROKERATOME
K981155 · HNO
Hawken Industries
Ophthalmic · 136d
Cleared Aug 14, 1998
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
K981761 · GKL
Sysmex Corp.
Hematology · 87d
Cleared Aug 14, 1998
CAROLINE GUIDE
K981809 · HAW
Surgical Solutions, Inc.
Neurology · 85d
Cleared Aug 14, 1998
NOSEBLEED NOSECLIP
K981966 · EMX
Michael M. Knott, M.D.
Ear, Nose, Throat · 71d
Cleared Aug 14, 1998
BC 900 SLIT LAMP
K982057 · HJO
Haag-Streit AG
Ophthalmic · 64d