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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126145–126168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1990
6000 PLUS MULTI-FORMAT VIDEO IMAGER
K900896 · LMC
International Imaging Electronics
Radiology · 62d
Cleared Apr 30, 1990
MP3000 COMPACT VIDEO IMAGER
K900899 · LMC
International Imaging Electronics
Radiology · 62d
Cleared Apr 30, 1990
MP3000 SERIES II COMPACT VIDEO IMAGER
K900900 · LMC
International Imaging Electronics
Radiology · 62d
Cleared Apr 30, 1990
MP4000 SERIES II COMPACT VIDEO IMAGER
K900901 · LMC
International Imaging Electronics
Radiology · 62d
Cleared Apr 30, 1990
22% POLYACRYLIC ACID GEL
K901051 · EBF
Pulpdent Corp.
Dental · 56d
Cleared Apr 30, 1990
MODEL 90489 PULSE OXIMETER MODULE
K901209 · DQA
Spacelabs, Inc.
Anesthesiology · 47d
Cleared Apr 30, 1990
DIGITAL IMAGE SCANNER, MODEL DIS-1000
K901423 · LMA
Lumisys, Inc.
Radiology · 35d
Cleared Apr 30, 1990
VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE
K901612 · DQA
Pace Tech, Inc.
Anesthesiology · 24d
Cleared Apr 27, 1990
VERA 103
K897143 · LYN
Madsen North America, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 27, 1990
IMPLA-MED TITANIUM, IMPLANT DEVICES
K900061 · DZE
Impla-Med
Dental · 114d
Cleared Apr 27, 1990
HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY
K901094 · JEY
Grimm & Norton
Dental · 51d
Cleared Apr 27, 1990
BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY
K901095 · JEY
Grimm & Norton
Dental · 51d
Cleared Apr 27, 1990
AMALGAM CONDENSER
K901178 · EKJ
American Medical Ceramics, Inc.
Dental · 45d
Cleared Apr 27, 1990
AMALCAP PLUS
K901256 · EJJ
Ivoclar North America, Inc.
Dental · 43d
Cleared Apr 27, 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
SEARS MODEL 9098 ITE HEARING AID
K901351 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 27, 1990
CHEM-SLEEVE
K901629 · KME
Haz-Med, Inc.
General Hospital · 28d
Cleared Apr 26, 1990
TELEMETRY POWER PACK MODEL 2
K891927 · FCP
Lucas & Rhea Mfg.
Gastroenterology & Urology · 394d
Cleared Apr 26, 1990
ENDOCOAGULATOR 2001 KLI
K895402 · HGI
Cabot Medical Corp.
Obstetrics & Gynecology · 231d
Cleared Apr 26, 1990
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · LYK
Trimedyne, Inc.
Cardiovascular · 225d
Cleared Apr 26, 1990
CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT
K896555 · KPQ
W. L. Systems, Inc.
Radiology · 160d
Cleared Apr 26, 1990
NEUROTENS
K896620 · GZJ
Henley Intl.
Neurology · 156d
Cleared Apr 26, 1990
MODEL ECG100 SIMULATOR
K897029 · DPS
Dynatech/Nevada, Inc.
Cardiovascular · 129d
Cleared Apr 26, 1990
TRAMSCOPE SYSTEM
K900598 · DPS
Marquette Electronics, Inc.
Cardiovascular · 77d