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
134977–135000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1988
CLEANTECH SYSTEM
K882539 · JKA
Schiff & Co.
Chemistry · 48d
Cleared Aug 08, 1988
PROFILE ONE OMNI
K882559 · JJE
Modular Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 08, 1988
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
K882586 · CIC
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
K882587 · CIX
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
EMIT HVA BARBITURATE ASSAY
K882611 · DIS
Syva Co.
Toxicology · 45d
Cleared Aug 08, 1988
PHARMACIA IGE RIA ULTRA
K882625 · DGC
Pharmacia, Inc.
Chemistry · 42d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Aug 08, 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · JJY
Amersham Corp.
Chemistry · 38d
Cleared Aug 08, 1988
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K882812 · JDI
Osteonics Corp.
Orthopedic · 32d
Cleared Aug 08, 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · LDJ
Syva Co.
Toxicology · 31d
Cleared Aug 08, 1988
WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM
K882890 · JDQ
Thackray USA
Orthopedic · 28d
Cleared Aug 08, 1988
SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
K882962 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Aug 08, 1988
SPEMBLY MEDICAL 142 CRYO UNIT
K882963 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 25d
Cleared Aug 08, 1988
IMX CKMB
K883013 · JHY
Abbott Laboratories
Chemistry · 20d
Cleared Aug 05, 1988
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
K862747 · BZQ
Atlas Researches , Ltd.
Anesthesiology · 746d
Cleared Aug 05, 1988
GL-35 COLPOSCOPIC LASER SYSTEM
K875314 · HHR
Laser Engineering, Inc.
Obstetrics & Gynecology · 220d
Cleared Aug 05, 1988
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
K881299 · ESD
Ear-Tronics, Inc.
Ear, Nose, Throat · 130d
Cleared Aug 05, 1988
SURGEONS GLOVES
K881374 · KGO
Interpro Intl., Inc.
General Hospital · 126d
Cleared Aug 05, 1988
MEDITRON MG-1000 MONOPOLAR GENERATOR
K882049 · GEI
Xylog Corp.
General & Plastic Surgery · 81d
Cleared Aug 05, 1988
LAURIER SANITARY NAPKIN
K882768 · HHD
Kao Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 05, 1988
SCHIFF REAGENT
K883217 · HZT
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Aug 04, 1988
EXL-14 MEDICAL LINEAR ACCELERATOR
K880200 · IYE
Mitsubishi Intl. Corp.
Radiology · 206d
Cleared Aug 04, 1988
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · KNS
Cook Urological, Inc.
Gastroenterology & Urology · 162d
Cleared Aug 04, 1988
BEAR 3 VENTILATOR
K881335 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 128d