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
123169–123192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 15, 1991
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184 · KWP
Acromed Corp.
Orthopedic · 88d
Cleared Feb 15, 1991
GERI TOTAL HIP SYSTEM
K905186 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 88d
Cleared Feb 15, 1991
PERIO PIK
K905188 · EFS
Teledyne Water Pik
Dental · 88d
Cleared Feb 15, 1991
OCHSNER 50 VASCULAR PROSTHESIS
K905270 · DSY
Intervascular, Inc.
Cardiovascular · 84d
Cleared Feb 15, 1991
ULTRACISION HARMONIC SCALPEL
K905315 · GEI
Ultracision, Inc.
General & Plastic Surgery · 79d
Cleared Feb 15, 1991
CONDOMS
K905854 · HIS
Barnetts, Inc.
Obstetrics & Gynecology · 59d
Cleared Feb 14, 1991
MEDTRONIC (R) MODEL 3625 SCREENER
K903690 · GZB
Medtronic Vascular
Neurology · 183d
Cleared Feb 14, 1991
FIBRINOTEST(TM) - FIBRINOGEN ASSAY
K903874 · GIS
Haemachem, Inc.
Hematology · 176d
Cleared Feb 14, 1991
EYE SEE INSTRUMENT
K905237 · HPN
King Tool, Inc.
Ophthalmic · 90d
Cleared Feb 14, 1991
CYBEX 6000
K905525 · IKK
Cybex
Physical Medicine · 66d