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
126721–126744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1990
MODEL 3586 RESUME LEAD
K890061 · GZB
Medtronic Vascular
Neurology · 476d
Cleared Apr 30, 1990
SYNTHES EXTERNAL FIXATION BONE CLIP
K894098 · JEC
Synthes (Usa)
Orthopedic · 325d
Cleared Apr 30, 1990
Y-ADAPTER W/THOUY BORST
K895580 · DYB
Angeion Corp.
Cardiovascular · 227d
Cleared Apr 30, 1990
GLAUCOMA MECHANICAL TREPHINE
K895813 · HQE
Trek Medical Products, Inc.
Ophthalmic · 210d
Cleared Apr 30, 1990
EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL
K896468 · ELW
Ivoclar North America, Inc.
Dental · 168d
Cleared Apr 30, 1990
KONICA KFDR-S
K896739 · LMA
Konica Medical Corp.
Radiology · 151d
Cleared Apr 30, 1990
PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL
K896915 · EJT
Jelenko Co.
Dental · 140d
Cleared Apr 30, 1990
DISCRETION, IN THE CANAL HEARING INSTRUMENT
K896995 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 140d
Cleared Apr 30, 1990
QEKG ELECTROCARDIOGRAPH
K897121 · DPS
Qmed, Inc.
Cardiovascular · 125d
Cleared Apr 30, 1990
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
K897154 · ESD
Nicolet Instrument Corp.
Ear, Nose, Throat · 125d
Cleared Apr 30, 1990
BRUKER R28 WHOLE-BODY MR SCANNER
K900026 · LNH
Bruker Medical Imaging, Inc.
Radiology · 117d
Cleared Apr 30, 1990
CO/CMD-1
K900322 · CCJ
Spirometrics, Inc.
Anesthesiology · 97d
Cleared Apr 30, 1990
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT
K900638 · KWL
Johnson & Johnson International
Orthopedic · 80d
Cleared Apr 30, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
K900818 · LGD
Vitek Systems, Inc.
Microbiology · 68d
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