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
97369–97392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1996
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
K961436 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 67d
Cleared Jun 21, 1996
IMPACT
K961694 · JQW
Matrix Technologies Corp.
Chemistry · 51d
Cleared Jun 21, 1996
TRANSAMERICA ELECTRODE
K961749 · GZJ
Transamerica Medical Systems
Neurology · 88d
Cleared Jun 21, 1996
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
K961853 · HRX
Acufex Microsurgical, Inc.
General & Plastic Surgery · 38d
Cleared Jun 21, 1996
ACS LH2 IMMUNOASSAY
K962041 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 24d
Cleared Jun 21, 1996
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
K962073 · FCM
Continental Medical Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 21, 1996
ACS CKMB II IMMUNOASSAY
K962126 · JHS
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Jun 20, 1996
MODEL LP-1000 VOLUME VENTILATOR
K952880 · CBK
Aequitron Medical, Inc.
Anesthesiology · 364d
Cleared Jun 20, 1996
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
K954202 · JPA
Medtronic Hemotec, Inc.
Hematology · 287d
Cleared Jun 20, 1996
AUTOVAC BP SYSTE, 2000 SERIES
K955010 · CAC
Boehringer Laboratories
Anesthesiology · 232d
Cleared Jun 20, 1996
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 20, 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 20, 1996
ULTIMATE SEAL
K960401 · KGB
Hans Rudolph, Inc.
Anesthesiology · 143d
Cleared Jun 20, 1996
MORE-L INJECTOR KIT PLUS
K960619 · CAZ
Incutech, Inc.
Anesthesiology · 128d
Cleared Jun 20, 1996
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
K962107 · HQY
Leonachi, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1996
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
K955550 · DTB
Intermedics, Inc.
Cardiovascular · 197d
Cleared Jun 19, 1996
ARISTO ESOPHAGEAL STETHOSCOPE
K961060 · BZT
Aristo Medical Products, Inc.
Anesthesiology · 93d
Cleared Jun 19, 1996
MICRO ANASTOMOSIS CLAMP
K961100 · DXC
R.S.P. Medical Management, Inc.
Cardiovascular · 92d
Cleared Jun 19, 1996
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM
K961121 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 19, 1996
BARD GRAFT SIZER
K961134 · DSY
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1996
BREAST TREATMENT AID
K961170 · IYE
S. and H. Engineering, Inc.
Radiology · 86d
Cleared Jun 19, 1996
SAM FACIAL IMPLANT
K961210 · LZK
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 83d
Cleared Jun 19, 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234 · HWC
Depuy, Inc.
Orthopedic · 82d
Cleared Jun 19, 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K961323 · KMF
Acme United Corp.
General & Plastic Surgery · 75d