FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80305–80328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2000
KAVO CORUND HANDPIECE 2013
K002708 · KOJ
Kavo America
Dental · 90d
Cleared Nov 28, 2000
WARTNER WART REMOVAL SYSTEM
K002714 · GEH
Wartner Medical Products
General & Plastic Surgery · 89d
Cleared Nov 28, 2000
SURGI-VISION PROSTATE COIL
K002916 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Nov 28, 2000
ZAP DUAL CURING LIGHT
K002991 · EBZ
Soft-Core Texas, Inc.
Dental · 64d
Cleared Nov 28, 2000
SELF ETCH BONDING PRIMER
K003011 · KLE
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Nov 28, 2000
RENEW LS-2
K003361 · EBF
Bisco, Inc.
Dental · 32d
Cleared Nov 28, 2000
PROCAD ADD-ON
K003373 · EIH
Ivoclar North America, Inc.
Dental · 29d
Cleared Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · LZO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Nov 28, 2000
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
K003473 · IZH
Elscintec Systems , Ltd.
Radiology · 20d
Cleared Nov 27, 2000
SOFTSENS
K001521 · GXY
Integrated Biosensing Technologies
Neurology · 195d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
K002263 · LDJ
Branan Medical Corp.
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264 · DIO
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
K002265 · DJC
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
K002268 · DJG
Branan Medical Corporation
Toxicology · 125d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
K002342 · JXM
Branan Medical Corporation
Toxicology · 118d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Dade Behring, Inc.
Chemistry · 75d
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069 · MID
Quest Intl., Inc.
Immunology · 56d
Cleared Nov 27, 2000
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 55d
Cleared Nov 27, 2000
COLOSCREEN-ES
K003359 · KHE
Helena Laboratories
Hematology · 31d
Cleared Nov 27, 2000
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · JZO
Pharmacia & Upjohn Co.
Immunology · 25d
Cleared Nov 27, 2000
SYNCHRON CONTROL
K003488 · JJY
Beckman Coulter, Inc.
Toxicology · 14d
Cleared Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · HCG
Cook, Inc.
Neurology · 270d
Cleared Nov 24, 2000
SCAN LT40 (40 CHANNELS)
K001564 · OLT
Neuro Scan Labs
Neurology · 189d
Cleared Nov 24, 2000
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K001692 · JXE
Neurosoft, Inc.
Neurology · 175d