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
132673–132696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1989
KMI OXY-BAN
K883848 · KPJ
Knight Medical, Inc.
General & Plastic Surgery · 171d
Cleared Mar 02, 1989
ASTRO TRACE (MODEL AT-01)
K884592 · DSA
The LE Blanc Corp.
Cardiovascular · 119d
Cleared Mar 02, 1989
MODEL OX-1 OXYGEN SATURATION MODULE
K884822 · DQA
Colin Medical Instruments Corp.
Anesthesiology · 104d
Cleared Mar 02, 1989
LYME ELISA TEST SYSTEM
K885317 · LSR
Zeus Scientific, Inc.
Microbiology · 62d
Cleared Mar 02, 1989
SARNS VENT CATHETER
K890024 · DWF
3M Company
Cardiovascular · 57d
Cleared Mar 02, 1989
DENTOCULT SM-STRIP MUTANS
K890199 · JSI
Orion Corp.
Microbiology · 43d
Cleared Mar 02, 1989
KONTRON PULSE OXIMETER 7840
K890299 · DQA
Kontron Instruments, Inc.
Anesthesiology · 42d
Cleared Mar 02, 1989
SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
K890353 · DXJ
Vidco, Inc.
Cardiovascular · 37d
Cleared Mar 02, 1989
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K890492 · DXO
Endosonics Corp.
Cardiovascular · 30d
Cleared Mar 02, 1989
WELLSHIRE EMLINK MODEL 1000
K890508 · DXH
American Executive Technology
Cardiovascular · 29d
Cleared Mar 02, 1989
LANCER - MODULAR POWER BASE
K890723 · ITI
Everest & Jennings, Inc.
Physical Medicine · 17d
Cleared Mar 01, 1989
SENSATIONS BRAND CONDOMS
K871358 · HIS
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 695d
Cleared Mar 01, 1989
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K882080 · HFM
Aequitron Medical, Inc.
Obstetrics & Gynecology · 288d
Cleared Mar 01, 1989
STANDARD LATEX CONDOM
K884399 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 133d
Cleared Mar 01, 1989
OBSTETRICAL SAFETY SYSTEM
K884868 · KNC
Buckman Co., Inc.
Obstetrics & Gynecology · 100d
Cleared Mar 01, 1989
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · EMA
Specialites Septodont
Dental · 90d
Cleared Mar 01, 1989
WIDEX BTE HEARING AID MODEL Q8
K885128 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 79d
Cleared Mar 01, 1989
KOTEX SECURITY TUBE TAMPONS
K885194 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 75d
Cleared Mar 01, 1989
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
K885339 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 01, 1989
INTERTECH UNIVERSAL HYDROPHOBIC FILTER
K890346 · CAH
Intertech/Ohio
General Hospital · 37d
Cleared Mar 01, 1989
MIDWIFERY/OBSTETRICAL FORCEPS
K890385 · HDA
Kinetic Medical Products
Obstetrics & Gynecology · 37d
Cleared Mar 01, 1989
KODAK X-OMATIC RA CASSETTE
K890750 · IXA
Eastman Kodak Company
Radiology · 16d
Cleared Feb 28, 1989
BT-1 INFUSION PUMP
K881759 · FRN
Ferring Laboratories, Inc.
General Hospital · 309d
Cleared Feb 28, 1989
M.I.P. - PUMP
K882249 · FRN
Intro-Med, Inc.
General Hospital · 273d