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
105193–105216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1994
AXSYM DIGOXIN
K944506 · KXT
Abbott Laboratories
Microbiology · 96d
Cleared Dec 19, 1994
ABBOTT IMX 2 ANALYZER
K944731 · JJI
Abbott Laboratories
Toxicology · 98d
Cleared Dec 19, 1994
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · GIM
Sherwood Medical Co.
Chemistry · 81d
Cleared Dec 19, 1994
STERISURE STERILIZATION WRAP
K944854 · FRG
Fiberweb North America, Inc.
General Hospital · 80d
Cleared Dec 19, 1994
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 76d
Cleared Dec 19, 1994
SPIFFY
K945650 · INN
Thames Valley Children'S Centre
Physical Medicine · 32d
Cleared Dec 15, 1994
HYSTEROMAT(TM) 3700
K921871 · HIG
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 969d
Cleared Dec 15, 1994
ATHENA HIGH SPEED HANDPIECE
K925678 · EFB
Athena Technology, Inc.
Dental · 765d
Cleared Dec 15, 1994
INFRARED EYE MOVEMENT MONITOR
K926312 · GWN
Microguide, Inc.
Neurology · 730d
Cleared Dec 15, 1994
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
K930536 · GZB
Neuromed, Inc.
Neurology · 687d
Cleared Dec 15, 1994
ATRIUM'S HYBRID PTFE
K933391 · DYF
Atrium Medical Corp.
Cardiovascular · 521d
Cleared Dec 15, 1994
UNITONE
K934572 · LLZ
Scitex Corporation , Ltd.
Radiology · 450d
Cleared Dec 15, 1994
HOWMEDICA SENTRY S TOTAL HIP SYSTEM
K935913 · LZO
Howmedica, Inc.
Orthopedic · 370d
Cleared Dec 15, 1994
L-CATH CONNECTOR ASSEMBLY
K940198 · GCD
Luther Medical Products, Inc.
General & Plastic Surgery · 336d
Cleared Dec 15, 1994
HYPERGRAPH
K941162 · DSB
Dermed Diagnostics, Inc.
Cardiovascular · 279d
Cleared Dec 15, 1994
ALAMAR ANTIBIOTIC SUSCEPTIBILITY
K941425 · LRG
Alamar Biosciences Laboratory, Inc.
Microbiology · 267d
Cleared Dec 15, 1994
MULTIPLE CO2 LAERS
K941838 · GEX
Mattioli Engineering, Srl
General & Plastic Surgery · 246d
Cleared Dec 15, 1994
HASSON OPEN LAPAROSCOPY CANNULA
K942447 · HET
Linvatec Corp.
Obstetrics & Gynecology · 206d
Cleared Dec 15, 1994
VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT
K942743 · GQW
Viro Research, Inc.
Microbiology · 188d
Cleared Dec 15, 1994
BONE ANCHOR
K942787 · JDR
Acu Med, Inc.
Orthopedic · 185d
Cleared Dec 15, 1994
SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
K942902 · MMK
Winfield Co., Inc.
General Hospital · 231d
Cleared Dec 15, 1994
CARDIAC OUTPUT OPTION 39
K943256 · DXG
Medical Data Electronics
Cardiovascular · 162d
Cleared Dec 15, 1994
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · KSA
Streck Laboratories, Inc.
Hematology · 161d
Cleared Dec 15, 1994
RF DRIVER, RADIO FREQUENCY DRIVER
K943406 · IYE
Pro-Comm, Inc.
Radiology · 154d