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
103705–103728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1995
IMAGERT
K942346 · IYE
Impac Medical Systems, Inc.
Radiology · 364d
Cleared May 15, 1995
IL TEST BETA-2MICROGLOBULIN
K943686 · JZG
Instrumentation Laboratory CO
Immunology · 290d
Cleared May 15, 1995
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
K943929 · KQX
Greenleaf Medical Systems, Inc.
Neurology · 276d
Cleared May 15, 1995
THE MODEL ACAPPELLA IN THE EAR HEARING AID
K943961 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 273d
Cleared May 15, 1995
TRANSAMERICAN CLASSIC TENS
K944280 · GZJ
Transamerica Biomedical, Inc.
Neurology · 258d
Cleared May 15, 1995
POLYSCAN DIGITAL SCANNER
K944684 · IYW
Mse Medizintechnik GmbH & Co. KG
Radiology · 235d
Cleared May 15, 1995
APOFIX CERVICAL SPINE FIXATION
K945022 · KWP
Sofamor Co.
Orthopedic · 214d
Cleared May 15, 1995
IMAGYN INTRAUTERINE INSEMINATION DEVICE
K945131 · HDR
Imagyn Medical, Inc.
Obstetrics & Gynecology · 208d
Cleared May 15, 1995
ADD POWER FAMILY , MICRO ADDSTAT
K945614 · GEX
Laserscope
General & Plastic Surgery · 181d
Cleared May 15, 1995
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
K946188 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 146d
Cleared May 15, 1995
MARDX ENA EIA TEST SYSTEM
K946218 · LJM
Hogan & Hartson
Immunology · 145d
Cleared May 15, 1995
CROSS PIN SCREW SYSTEM
K946228 · JDW
Depuy, Inc.
Orthopedic · 144d
Cleared May 15, 1995
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
K950010 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 132d
Cleared May 15, 1995
MARDX MITOCHONDRIA EIA TEST SYSTEM
K950110 · LJM
Hogan & Hartson
Immunology · 124d
Cleared May 15, 1995
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128 · CEK
Emd Chemicals, Inc.
Chemistry · 123d
Cleared May 15, 1995
RINGLOC CONSTRAINED LINER
K950202 · KWZ
Biomet, Inc.
Orthopedic · 117d
Cleared May 15, 1995
ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
K950242 · HRX
Argus Medical Co., Inc.
Orthopedic · 115d
Cleared May 15, 1995
NMI SOFTWARE
K950270 · OMB
Nicolet Biomedical, Inc.
Neurology · 112d
Cleared May 15, 1995
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K950420 · HGM
Analogic Corp.
Obstetrics & Gynecology · 104d
Cleared May 15, 1995
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
K950524 · JKC
Nichols Institute
Chemistry · 105d
Cleared May 15, 1995
RICH-MAR US-II ULTRASOUND
K950564 · IMI
Rich-Mar Corp.
Physical Medicine · 96d
Cleared May 15, 1995
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · DXE
Applied Medical Resources
Cardiovascular · 95d
Cleared May 15, 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · DXY
Medtronic Vascular
Cardiovascular · 87d
Cleared May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d