FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90265–90288 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1998
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
K980472 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d
Cleared Apr 09, 1998
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
K980541 · LMD
Barco NV Display Systems
Radiology · 57d
Cleared Apr 09, 1998
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
K980617 · GDW
Urohealth Systems, Inc.
General & Plastic Surgery · 76d
Cleared Apr 09, 1998
VACUETTE HOLDEX
K980768 · FMI
Greiner Meditech, Inc.
General Hospital · 41d
Cleared Apr 08, 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · DPT
International Biophysics Corp.
Cardiovascular · 569d
Cleared Apr 08, 1998
BETTER-TUBING
K964205 · DWF
Circulatory Technology, Inc.
Cardiovascular · 537d
Cleared Apr 08, 1998
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR...
K973697 · MUW
Airperm, Inc.
Ophthalmic · 194d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW
Light Diagnostics
Microbiology · 142d
Cleared Apr 08, 1998
GYNEX ENDOSPECULUM
K980237 · KNA
Gynex Corp.
Obstetrics & Gynecology · 75d
Cleared Apr 08, 1998
FETAL D TECTION KIT
K980314 · LIM
Biopool Intl., Inc.
Hematology · 71d
Cleared Apr 08, 1998
COLOURED POWDWR-FREE SURGICAL GLOVES
K980412 · KGO
Kenwell International , Ltd.
General Hospital · 64d
Cleared Apr 08, 1998
URESIL NEPHRO-URETERAL STENT
K980889 · LJE
Uresil Corp.
Gastroenterology & Urology · 30d
Cleared Apr 07, 1998
KEELER TEARSCOPE-PLUS
K973064 · HJO
Keeler Instruments, Inc.
Ophthalmic · 232d
Cleared Apr 07, 1998
HORTMANN AMDIS-OAE OAE ANALYZER
K980505 · EWO
Hortmann AG
Ear, Nose, Throat · 57d
Cleared Apr 07, 1998
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT...
K980554 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 53d
Cleared Apr 07, 1998
NEVA SYSTEM
K980627 · LIL
Urometrics, Inc.
Gastroenterology & Urology · 48d
Cleared Apr 06, 1998
MANAN POTTS-COURNAND NEEDLE
K974742 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN
K974743 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · DRC
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
RELEASABLE FORCE MODULE
K980151 · DZB
Ortho Kinetics Corp.
Dental · 80d
Cleared Apr 06, 1998
IV STANDS
K980336 · FOX
Clinton Industries, Inc.
General Hospital · 68d
Cleared Apr 06, 1998
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980470 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 59d
Cleared Apr 06, 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · DIF
Bio-Rad
Toxicology · 46d
Cleared Apr 03, 1998
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K972824 · BWF
Pn Medical
Anesthesiology · 247d