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
79033–79056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · GZJ
Biomedical Life Systems, Inc.
Neurology · 140d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 12, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K010770 · MWI
Bci, Inc.
Cardiovascular · 90d
Cleared Jun 12, 2001
BIOCELLECT
K010775 · LYC
Imtec Corp.
Dental · 90d
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jun 12, 2001
HEARTCARD, MODEL 5258
K010945 · DXH
Instromedix
Cardiovascular · 75d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972 · MNI
Depuyacromed
Orthopedic · 71d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · MBI
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 12, 2001
NAC PLUS NEEDLELESS ACCESS CONNECTOR
K011193 · FPA
Porex Medical Products
General Hospital · 54d
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