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
78529–78552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2001
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
K011336 · FPA
Churchill Medical Systems, Inc.
General Hospital · 41d
Cleared Jun 12, 2001
MM-87 MOTOR-DRIVE MANIPULATOR
K011420 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 34d
Cleared Jun 12, 2001
BALLERT CRANIAL MOLDING HELMET
K011433 · MVA
Gema, Inc.
Neurology · 33d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · HSB
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · LBZ
Syva Co., Dade Behring, Inc.
Toxicology · 19d
Cleared Jun 11, 2001
EN BLOC BIOPSY SYSTEM
K003190 · GEI
Neothermia Corp.
General & Plastic Surgery · 243d
Cleared Jun 11, 2001
H-SCRIBE
K004017 · MLO
Mortara Instrument, Inc.
Cardiovascular · 166d
Cleared Jun 11, 2001
IMMUNOWELL EA (D) IGG TEST
K010301 · LSE
Genbio
Microbiology · 130d
Cleared Jun 11, 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT...
K010634 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 101d
Cleared Jun 11, 2001
BPFONE, MODEL UA 767IT
K010751 · DXN
Medical Monitors Pty Limited
Cardiovascular · 90d
Cleared Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · KNF
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 11, 2001
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
K010760 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 11, 2001
ISLAND WOUND DRESSING WITH MICROBAN
K010951 · FRO
Island Dressing, LLC
General & Plastic Surgery · 75d
Cleared Jun 11, 2001
RESIN CEM
K011431 · EMA
S & C Polymer GmbH
Dental · 33d
Cleared Jun 08, 2001
SIGMA DELTA
K002343 · CAD
Penlon , Ltd.
Anesthesiology · 311d
Cleared Jun 08, 2001
ORIGEN DUAL LUMEN CATHETER
K003288 · DQO
Origen Biomedical, Inc.
Cardiovascular · 231d
Cleared Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
K003560 · FIN
Mar Cor Services, Inc.
Gastroenterology & Urology · 203d
Cleared Jun 08, 2001
BREAST-BOARD (MULTIPLE)
K003778 · IYE
Arplay Medical S.A.
Radiology · 183d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · DXN
Welch Allyn, Inc.
Cardiovascular · 137d
Cleared Jun 08, 2001
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
K010791 · DXH
Adsis , Ltd.
Cardiovascular · 85d
Cleared Jun 08, 2001
CARDIAC VIEW, MODEL 2001
K010802 · MOS
Magna-Lab, Inc.
Radiology · 84d
Cleared Jun 08, 2001
INSULIN PEN NEEDLE ADAPTER
K010887 · FMI
Ohana Needle Co.
General Hospital · 74d
Cleared Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 67d