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
95257–95280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1996
EVITA 4
K961687 · CBK
Drager, Inc.
Anesthesiology · 226d
Cleared Dec 13, 1996
KARL STORZ FRIMBERGER VARIOGUIDE
K962212 · FDT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 186d
Cleared Dec 13, 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · GGP
Behring Diagnostics, Inc.
Hematology · 136d
Cleared Dec 13, 1996
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062 · KXT
Beckman Instruments, Inc.
Toxicology · 128d
Cleared Dec 13, 1996
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d
Cleared Dec 13, 1996
NICCHECK I
K963733 · MRS
Dynagen, Inc.
Toxicology · 88d
Cleared Dec 13, 1996
MANAN D BAG
K963849 · EXF
Manan Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Dec 13, 1996
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · KLT
Bayer Corp.
Toxicology · 64d
Cleared Dec 13, 1996
JEL-40 (CODE NAME RD-0430)
K964158 · EJT
Jelenko Co.
Dental · 58d
Cleared Dec 13, 1996
C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172,...
K964173 · FET
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 56d
Cleared Dec 13, 1996
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
K964328 · JEY
Synthes (Usa)
Dental · 44d
Cleared Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 42d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
K964415 · DHR
Kamiya Technology Services
Immunology · 73d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
K964418 · DHR
Kamiya Technology Services
Immunology · 73d
Cleared Dec 13, 1996
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
K964535 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 31d
Cleared Dec 13, 1996
TRIAD II DISINFECTANT CLEANER AND DEODORANT
K964610 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 25d
Cleared Dec 13, 1996
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
K964613 · LRJ
S.C. Johnson & Son, Inc.
General Hospital · 25d
Cleared Dec 13, 1996
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1:...
K964640 · JJY
Canyon Diagnostics, Inc.
Chemistry · 24d
Cleared Dec 13, 1996
COVERAGE HBV
K964749 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 17d
Cleared Dec 12, 1996
EQUINOX DIGITAL EEG SYSTEM
K962447 · GWQ
Physiometrix, Inc.
Neurology · 171d
Cleared Dec 12, 1996
OLYMPUS MOBILE CHAIR/COUCH
K962528 · FZK
Keymed (Medical & Industrial...
Radiology · 168d
Cleared Dec 12, 1996
BILIBED PHOTOTHERAPY LAMP
K962612 · LBI
Medela, Inc.
General Hospital · 162d
Cleared Dec 12, 1996
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K963669 · GWL
Astro-Med, Inc.
Neurology · 90d
Cleared Dec 12, 1996
LOVING SMARTER - SAFER SEX
K963679 · HIS
Loving Smarter, Inc.
Obstetrics & Gynecology · 90d