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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122569–122592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1991
ENDOCOAGULATOR KRS568(TM) LASER
K904700 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 126d
Cleared Feb 19, 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 91d
Cleared Feb 19, 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · DQY
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Feb 19, 1991
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · HIS
Aladan Corp.
Obstetrics & Gynecology · 88d
Cleared Feb 19, 1991
CATALOG NUMBER 2609 LEG PLATE
K905295 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 84d
Cleared Feb 19, 1991
ALGODERM ALGINATE WOUND DRESSING
K905314 · FRO
Les Laboratorires Brothier, S.A.
General & Plastic Surgery · 83d
Cleared Feb 19, 1991
THE DART
K905549 · HIF
Dexide, Inc.
Obstetrics & Gynecology · 70d
Cleared Feb 19, 1991
SILICONE COATED GUIDEWIRES
K905581 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Feb 19, 1991
FST CATH-UD CATHETER
K905641 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 19, 1991
RICHARD-ALLAN CLAMP COVERS
K905682 · FSM
Richard-Allan Medical
General & Plastic Surgery · 62d
Cleared Feb 19, 1991
RICHARD-ALLAN SHEET CLIP
K905701 · KKX
Richard-Allan Medical
General Hospital · 61d
Cleared Feb 19, 1991
ROMFLEX
K905718 · BXB
Paraflex Corp.
Physical Medicine · 60d
Cleared Feb 19, 1991
IONOBOND
K905724 · EJK
Micro-Vac, Inc.
Dental · 61d
Cleared Feb 19, 1991
MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
K905834 · LNH
Summit World Trade Corp.
Radiology · 50d
Cleared Feb 19, 1991
MRP-7000: SUPPLEMENTAL R/F COILS
K905835 · LNH
Summit World Trade Corp.
Radiology · 50d
Cleared Feb 19, 1991
SOM 6V
K910357 · FSO
Jedmed Instrument Co.
General & Plastic Surgery · 21d
Cleared Feb 19, 1991
ZARA CHIN IMPLANT
K910456 · FWP
Byron Medical
General & Plastic Surgery · 15d
Cleared Feb 19, 1991
ZARA EXTENDED CHIN IMPLANT
K910457 · FWP
Byron Medical
General & Plastic Surgery · 15d
Cleared Feb 19, 1991
ZARA SOFT TIP CHIN IMPLANT
K910458 · FWP
Byron Medical
General & Plastic Surgery · 15d
Cleared Feb 19, 1991
QUALTEX SURGICAL DRAPE
K910495 · KKX
Deroyal Industries, Inc.
General Hospital · 14d
Cleared Feb 19, 1991
ACCUFLATE
K910512 · KCY
Instrumed, Inc.
General & Plastic Surgery · 14d
Cleared Feb 19, 1991
DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES
K910542 · LYY
21st Century Group
General Hospital · 14d
Cleared Feb 15, 1991
IRRIGATION CATHETER 4, 6 AND 10 FRENCH
K902256 · DQY
Applied Vascular Devices, Inc.
Cardiovascular · 270d
Cleared Feb 15, 1991
MULTI-LUMEN CENTRAL VENOUS CATHETER SET
K904404 · DQY
Arrow Intl., Inc.
Cardiovascular · 143d