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
136873–136896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1988
GUARDALL SHIELD
K875008 · FXX
Anago, Inc.
General Hospital · 98d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · DIO
Abbott Laboratories
Toxicology · 67d
Cleared Mar 11, 1988
YESNG MODEL 200S11 ELECTROSURGICAL UNIT
K880064 · GEI
Ferguson Medical
General & Plastic Surgery · 64d
Cleared Mar 11, 1988
YESNG MODEL 500SII ELECTROSURGICAL UNIT
K880073 · GEI
Ferguson Medical
General & Plastic Surgery · 60d
Cleared Mar 11, 1988
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
K880172 · LKW
Cooper Lasersonics, Inc.
Neurology · 56d
Cleared Mar 11, 1988
POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
K880206 · NAD
Laivan Corp.
General & Plastic Surgery · 56d
Cleared Mar 11, 1988
BLAKEMORE RETAINER
K880253 · FEF
Orthopedic Systems, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 11, 1988
DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE
K880513 · KKX
Taub Industries
General Hospital · 31d
Cleared Mar 11, 1988
COHERENT XA-40 CO2 SURGICAL LASER
K880603 · GEX
Coherent Medical Group
General & Plastic Surgery · 28d
Cleared Mar 11, 1988
TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
K880757 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 15d
Cleared Mar 11, 1988
SKILCRAFT
K880785 · KDD
Pennsylvania Association For the Blind
General & Plastic Surgery · 14d
Cleared Mar 11, 1988
SPINAL NEEDLE
K880812 · GDM
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 14d
Cleared Mar 11, 1988
SELF-RETAINING SOFT TISSUE RETRACTOR
K880813 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 14d
Cleared Mar 10, 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · JWH
Osteonics Corp.
Orthopedic · 121d
Cleared Mar 10, 1988
FLORIDA PROBE
K875076 · EIX
Florida Probe Corp.
Dental · 92d
Cleared Mar 10, 1988
SIEMENS NEUROTON 826 AND 827
K875238 · IPF
Elmed, Inc.
Physical Medicine · 79d
Cleared Mar 10, 1988
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · EBF
Bisco, Inc.
Dental · 72d
Cleared Mar 09, 1988
CONTATTO CONDOMS
K871744 · HIS
Razi Corp.
Obstetrics & Gynecology · 309d
Cleared Mar 09, 1988
KETAC-CONDITIONER
K872984 · EMA
Espe GmbH (Us)
Dental · 222d
Cleared Mar 09, 1988
INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
K873498 · BXR
Dhd Medical Products Div. Diemolding...
Anesthesiology · 191d
Cleared Mar 09, 1988
AUTOTRANSFUSION APPARATUS
K873807 · CAC
Biodynamics Corp.
Anesthesiology · 173d
Cleared Mar 09, 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · GKZ
Coulter Electronics, Inc.
Hematology · 92d
Cleared Mar 09, 1988
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
K875089 · JPA
Hemotec, Inc.
Hematology · 91d