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
86497–86520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 19, 1999
SHEER GLYDE DAMS
K990067 · MSC
Louise C. Myers
Obstetrics & Gynecology · 42d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED
K990081 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 39d
Cleared Feb 19, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K990117 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 37d
Cleared Feb 19, 1999
GUTHRIE PRIME POWDER-FREE
K990228 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 25d
Cleared Feb 18, 1999
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · HAX
Friddle'S Orthopedic Appliances, Inc.
Neurology · 360d
Cleared Feb 18, 1999
BAHO AUTOCLAVABLE LAPAROSCOPE
K982276 · HET
Microptix Int'L, LLC
Obstetrics & Gynecology · 234d
Cleared Feb 18, 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
K983160 · LPL
Hydron , Ltd.
Ophthalmic · 162d
Cleared Feb 18, 1999
BLASTOCYST MEDIUM
K983580 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 18, 1999
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS),...
K983586 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 128d