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
127057–127080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1990
ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
K895854 · EJF
Acme-Monaco Corp.
Dental · 188d
Cleared Apr 09, 1990
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
K895945 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared Apr 09, 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1990
SPAG PAK
K896608 · BYL
Viratek, Inc.
Anesthesiology · 139d
Cleared Apr 09, 1990
WILLI GELLER CERAMIC CREATION & SURPRISE
K900209 · EIH
Creation North America, Inc.
Dental · 82d
Cleared Apr 09, 1990
DISPOSABLE BIPOLAR COAGULATING FORCEPS
K900533 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 76d
Cleared Apr 09, 1990
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
K900828 · JXR
The Perkin-Elmer Corp.
Toxicology · 47d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
K901027 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
K901059 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · GDJ
United States Surgical, A Division of...
General & Plastic Surgery · 32d
Cleared Apr 09, 1990
LATEX EXAMINATION GLOVES
K901136 · LYY
Qilu (China) Good Luck Chemical...
General Hospital · 28d
Cleared Apr 09, 1990
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K901141 · JJC
Baxter Healthcare Corp
Chemistry · 27d
Cleared Apr 09, 1990
LATEX EXAMINATION GLOVES
K901148 · LYY
Pt. Scitech Industries
General Hospital · 28d
Cleared Apr 09, 1990
PATIENT EXAMINATION GLOVES
K901479 · LYY
Hexza World Trade Sdn. Bhd.
General Hospital · 13d
Cleared Apr 06, 1990
SONICATH(TM) 5 F
K895542 · DQO
Boston Scientific Corp
Cardiovascular · 205d
Cleared Apr 06, 1990
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · EFB
Dentsply Intl.
Dental · 88d
Cleared Apr 05, 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989 · KTT
Origin Medsystems, Inc.
Orthopedic · 401d
Cleared Apr 05, 1990
SALIVA ALCOHOL TEST
K894001 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Chemistry · 304d
Cleared Apr 05, 1990
POINT CHECKER COLOR STRIP THERMOMETER
K894893 · FQZ
Kyowa Medex Co., Ltd.
General Hospital · 247d
Cleared Apr 05, 1990
RX02 EMERGENCY MEDICAL OXYGEN
K895956 · CAN
Progressive Medical Applications Corp.
Anesthesiology · 176d
Cleared Apr 05, 1990
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
K896857 · CAC
Solco Basle, Inc.
Anesthesiology · 121d
Cleared Apr 05, 1990
SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
K896858 · CAC
Solco Basle, Inc.
Anesthesiology · 121d
Cleared Apr 05, 1990
MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES
K900253 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 78d