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
71161–71184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA...
K032464 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 11d
Cleared Aug 22, 2003
SPIDERVIEW
K032466 · MWJ
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Aug 22, 2003
VIATRONIX V3D EXPLORER, REVISION 1.2
K032483 · LLZ
Viatronix, Inc.
Radiology · 10d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367 · JWH
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
K030574 · KMF
Glustitch, Inc.
General & Plastic Surgery · 178d
Cleared Aug 21, 2003
DENTAPORT ZX
K031204 · EKX
J. Morita USA, Inc.
Dental · 127d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · HRS
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735 · HNO
Ciba Vision Corporation
Ophthalmic · 78d
Cleared Aug 21, 2003
BODYGUARD INFUSION SYSTEM
K031749 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 77d
Cleared Aug 21, 2003
SHIMADZU COLLIMATOR R-30H
K031771 · IZX
Shimadzu Corp.
Radiology · 73d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · HBL
Image-Guided Neurologics, Inc.
Neurology · 64d
Cleared Aug 21, 2003
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351
K031907 · FLL
Norm Pacific Automation Corp.
General Hospital · 62d
Cleared Aug 21, 2003
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
K031954 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 57d
Cleared Aug 21, 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · GCT
Linvatec Corp.
Gastroenterology & Urology · 55d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057 · DIO
Branan Medical Corp.
Toxicology · 50d
Cleared Aug 21, 2003
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8
K032090 · MOS
Mri Devices Corp.
Radiology · 45d
Cleared Aug 21, 2003
NOMOS CORVUS 5.0M
K032209 · MUJ
Nomos Corp.
Radiology · 34d
Cleared Aug 21, 2003
14G CORMARK BIOPSY SITE IDENTIFIER
K032217 · FZP
Artemis Medical, Inc.
General & Plastic Surgery · 31d
Cleared Aug 21, 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
K032252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared Aug 21, 2003
MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K032282 · EZX
Implex Corp.
General & Plastic Surgery · 28d
Cleared Aug 21, 2003
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
K032285 · JIT
Olympus America, Inc.
Chemistry · 28d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 21, 2003
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
K032301 · OMP
Neogen Technologies, Inc.
General & Plastic Surgery · 27d