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
122905–122928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
BACTEC NR-860
K910835 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 12d
Cleared Mar 11, 1991
PVC VINYL GLOVE
K910891 · LYZ
Pioneer Sundries Products , Ltd.
General Hospital · 7d
Cleared Mar 08, 1991
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
K901975 · LKH
Savyon Diagnostics , Ltd.
Microbiology · 311d
Cleared Mar 08, 1991
PATIENT EXAMINATION GLOVES
K904697 · LYY
Shamrock Marketing Co.
General Hospital · 143d
Cleared Mar 08, 1991
HIGH SPEED CORE CUT BIOPSY GUN
K905556 · FCG
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 08, 1991
CCC CROWN-CORE-CUT-NEEDLE
K905557 · KNW
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 08, 1991
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
K905603 · LNH
Philips Medical Systems, Inc.
Radiology · 85d
Cleared Mar 08, 1991
543 SERIES BTE
K905680 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 08, 1991
STRATOFUSE PCA INFUSER
K905696 · FRN
Strato Medical Corp.
General Hospital · 77d
Cleared Mar 08, 1991
NON-STERILE PATIENT EXAMINATION GLOVES
K905755 · LYY
Superior Healthcare Group, Inc.
General Hospital · 71d
Cleared Mar 08, 1991
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028 · ESD
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Mar 08, 1991
SYSNPAR PORCELAIN
K910303 · ELL
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Mar 08, 1991
EVIDENCE BIOLOGICAL INDICATOR
K910417 · FRC
Skyland Scientific Services, Inc.
General Hospital · 37d
Cleared Mar 08, 1991
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE
K910471 · GAZ
Baxter Healthcare Corp
General Hospital · 32d
Cleared Mar 07, 1991
JOSLYN EO STERILIZER/ EO MODERNIZATION KIT
K901146 · FLF
Joslyn Valve Corp.
General Hospital · 360d
Cleared Mar 07, 1991
STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
K901883 · HAW
Stereotactic Image Systems, Inc.
Neurology · 315d
Cleared Mar 07, 1991
BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD
K902588 · KOC
Gambro-Hospal, Inc.
Gastroenterology & Urology · 268d
Cleared Mar 07, 1991
VYGON LIFEVAC PICC
K903648 · LJS
Vygon Corp.
General Hospital · 206d
Cleared Mar 07, 1991
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
K904878 · IWP
Hpi, Inc.
Radiology · 128d
Cleared Mar 07, 1991
BODY COMPOSITION ANALYZER
K904970 · DSB
Body Composition Analog, Inc.
Cardiovascular · 122d
Cleared Mar 07, 1991
ANTERIOR NECK CONTOUR COIL
K905512 · LNH
Magnetic Research, Inc.
Radiology · 87d