FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80809–80832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2000
B-D ULTRA-FINE III PEN NEEDLE
K002938 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 69d
Cleared Nov 29, 2000
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K002986 · HQC
A.R.C. Laser AG
Ophthalmic · 65d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · GGM
Bio-Rad
Hematology · 62d
Cleared Nov 29, 2000
FASTPACK CONTROL
K003095 · JJX
Qualigen, Inc.
Immunology · 57d
Cleared Nov 29, 2000
ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50...
K003213 · LYY
Concept Rubber Products Sdn Bhd
General Hospital · 47d
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · LAF
Worldwide Medical Corp.
Toxicology · 383d
Cleared Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE...
K002064 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 144d
Cleared Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · LGC
Diamedix Corp.
Microbiology · 126d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · CBI
Cook, Inc.
Anesthesiology · 124d
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