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
112993–113016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1993
DIGIRAY
K926098 · LMD
Telescan Corp.
Radiology · 204d
Cleared Jun 25, 1993
POWDER FREE LATEX EXAMINATION GLOVES
K926277 · LYY
A.P. Rubber Co., Ltd.
General Hospital · 193d
Cleared Jun 25, 1993
PREDICTA ERYTHROPOIETIN KIT
K926390 · GGT
Genzyme Corp.
Hematology · 185d
Cleared Jun 25, 1993
FUJINON VIDEO LAPAROSCOPE, MODIFICATION
K926444 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 184d
Cleared Jun 25, 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930469 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 148d
Cleared Jun 25, 1993
ARGON HANDPIECES
K930497 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 144d
Cleared Jun 25, 1993
HIFLO FILTERED INSUFFLATION TUBING
K930508 · FCX
W. J. Medical Instruments, Inc.
Gastroenterology & Urology · 144d
Cleared Jun 25, 1993
STEALTH SURGICAL IRRIGATOR ASPIRATOR
K930511 · GCJ
W. J. Medical Instruments, Inc.
General & Plastic Surgery · 144d
Cleared Jun 25, 1993
DPD DEFIBRILLATOR
K930548 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 25, 1993
MI-15 EXAM SURGICAL LIGHT
K930897 · FTD
Medical Illumination, Inc.
General & Plastic Surgery · 123d
Cleared Jun 25, 1993
KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES
K931018 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 119d
Cleared Jun 25, 1993
MODEL 110 ND:YAG LASER
K931051 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 116d
Cleared Jun 25, 1993
INSTRUMENTS FOR LAPAROSCOPIC USE
K931142 · GCJ
Li Medical Technologies, Inc.
General & Plastic Surgery · 112d
Cleared Jun 25, 1993
WOODLYN OPERATION MICROSCOPE
K931303 · FSO
Woodlyn, Inc.
General & Plastic Surgery · 102d
Cleared Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · CGA
Heraeus Kulzer, Inc.
Chemistry · 102d
Cleared Jun 25, 1993
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jun 25, 1993
QUANTIMETRIX C-CLEAR(TM)
K931523 · JMA
Quantimetrix Corp.
Chemistry · 91d
Cleared Jun 25, 1993
MICROVASIVE INSURG GEENEN CBD GUIDE WIRE
K931650 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Jun 24, 1993
COMPATIT R
K913582 · ELM
Wilde-USA, Inc.
Dental · 682d
Cleared Jun 24, 1993
CPS ACETABULAR COMPONENT
K915527 · JDL
Implantology Corp.
Orthopedic · 562d
Cleared Jun 24, 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · KWP
Buckman Co., Inc.
Orthopedic · 476d
Cleared Jun 24, 1993
M30 IN THE EAR HEARING AID
K922501 · ESD
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 24, 1993
M32 IN THE EAR HEARING AID
K922502 · ESD
Electone, Inc.
Ear, Nose, Throat · 393d
Cleared Jun 24, 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · KWQ
Synthes (Usa)
Orthopedic · 374d