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
87001–87024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1999
MODIFICATION OF VENTURI VENTILATOR
K990429 · CBK
Cardiopulmonary Corp.
Anesthesiology · 13d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Boston Scientific Corp
Cardiovascular · 232d
Cleared Feb 23, 1999
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
K982967 · GZJ
Woodside Biomedical, Inc.
Neurology · 182d
Cleared Feb 23, 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · DXC
Radi Medical Systems AB
Cardiovascular · 144d
Cleared Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE...
K984220 · FTL
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Feb 23, 1999
ORL-E-92 SURGICAL DRILL SYSTEM
K984244 · EFB
Bien Air USA, Inc.
Dental · 88d
Cleared Feb 23, 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
K984619 · MVJ
The Binding Site, Ltd.
Immunology · 56d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337 · DKZ
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Feb 22, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K983208 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 161d
Cleared Feb 22, 1999
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K984150 · DRF
Ep Medsystems
Cardiovascular · 95d
Cleared Feb 22, 1999
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
K984208 · FRO
Argentum International, LLC
General & Plastic Surgery · 90d
Cleared Feb 22, 1999
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K984294 · DSY
Intervascular, Inc.
Cardiovascular · 83d
Cleared Feb 22, 1999
NORMLGEL 0.9% ISOTONIC SALINE GEL
K984368 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 77d
Cleared Feb 22, 1999
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
K984441 · FPA
I-Flow Corp.
General Hospital · 70d
Cleared Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · LCX
Abbott Laboratories
Chemistry · 14d
Cleared Feb 22, 1999
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250
K990380 · DXN
Meditec Co., Ltd.
Cardiovascular · 14d
Cleared Feb 19, 1999
E-FAX SYSTEM
K982034 · DXH
Blakbag, Ltd., Division of Coherent...
Cardiovascular · 254d
Cleared Feb 19, 1999
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
K982867 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 189d
Cleared Feb 19, 1999
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139 · MOS
GE Medical Systems
Radiology · 164d
Cleared Feb 19, 1999
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · IZQ
Nycomed Amersham Imaging
Cardiovascular · 151d
Cleared Feb 19, 1999
NITRILE POWDER FREE EXAMINATION GLOVES
K983334 · LZA
Cranberry (M) Sdn. Bhd.
General Hospital · 149d
Cleared Feb 19, 1999
BURETROL SOLUTION SETS
K984381 · FPA
Baxter Healthcare Corp
General Hospital · 73d
Cleared Feb 19, 1999
HUMMER TRAK SYSTEM
K990038 · ERL
Stryker Endoscopy
Ear, Nose, Throat · 44d
Cleared Feb 19, 1999
TEL-ECHO SYSTEM
K990052 · LLZ
Innovative Medical Solutions, Inc.
Radiology · 43d