FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121873–121896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1991
ORIGINALS
K911277 · HQY
Face 2 Face Corp.
Ophthalmic · 73d
Cleared Jun 06, 1991
ELITE SYSTEM
K911416 · LXJ
Gfb Intl. Trading, Inc.
Physical Medicine · 66d
Cleared Jun 06, 1991
I.V. EXTENDER SET
K911451 · FPB
Filtertek, Inc.
General Hospital · 64d
Cleared Jun 06, 1991
LAPAROSCOPIC RINSING CONTAINER
K911488 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 63d
Cleared Jun 06, 1991
INLAY 90
K911546 · EJT
Metalor Dental USA Corp.
Dental · 66d
Cleared Jun 06, 1991
MARK 5 ROBOTIC PIPETTOR
K912228 · JQW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jun 05, 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
K910989 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 04, 1991
NEUROSEARCH-24 OR NRS-24
K904269 · GWQ
Lexicor Medical Technology, Inc.
Neurology · 259d
Cleared Jun 04, 1991
POINTER F-3 TENS
K904388 · GZJ
Oms Medical Supplies, Inc.
Neurology · 252d
Cleared Jun 04, 1991
4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP
K905218 · FPA
Marquette Medical, Inc.
General Hospital · 196d
Cleared Jun 04, 1991
4' LOW VOLUME IV EXTENSION SET
K905219 · FPA
Marquette Medical, Inc.
General Hospital · 196d
Cleared Jun 04, 1991
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K905230 · GZJ
Biomedical Life Systems, Inc.
Neurology · 196d
Cleared Jun 04, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A
K905377 · GZJ
Biomedical Life Systems, Inc.
Neurology · 186d
Cleared Jun 04, 1991
LITHOTRIPTOR SYSTEM MODEL 27080
K905553 · FFK
Karl Storz GmbH & Co. (Kst)
Gastroenterology & Urology · 175d
Cleared Jun 04, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K905570 · GZJ
Biomedical Life Systems, Inc.
Neurology · 174d
Cleared Jun 04, 1991
CONDOMS (RUBBER CONTRACEPTIVES)
K910284 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 132d
Cleared Jun 04, 1991
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
K911041 · IXA
Invotec International, Inc.
Radiology · 88d
Cleared Jun 04, 1991
PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
K911581 · FGE
Johnson & Johnson Interventional Systems
Gastroenterology & Urology · 56d
Cleared Jun 03, 1991
NASCOR OXYDOME
K905627 · BYL
Nascor Pty. , Ltd.
Anesthesiology · 171d
Cleared Jun 03, 1991
CHARISMA
K910263 · EBF
Kulzer, Inc.
Dental · 132d
Cleared Jun 03, 1991
STABIDENT LOCAL ANESTHESIA SYSTEM
K910446 · DZM
Fairfax Dental, Inc.
Dental · 140d
Cleared Jun 03, 1991
CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW
K910550 · HIS
Safetex Corp.
Obstetrics & Gynecology · 116d
Cleared Jun 03, 1991
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
K910565 · FOZ
Menlo Care, Inc.
General Hospital · 115d
Cleared Jun 03, 1991
VERSACATH(TM) MULTILUMEN SYSTEM
K910566 · FOZ
Menlo Care, Inc.
General Hospital · 115d