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
86137–86160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K990943 · DHX
Ortho-Clinical Diagnostics, Inc.
Immunology · 71d
Cleared Jun 01, 1999
KSEA EPIDUROSCOPE
K991051 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Jun 01, 1999
COAG-A-MATE MAX
K991101 · GKP
Organon Teknika Corp.
Hematology · 61d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · JIX
Dade Behring, Inc.
Chemistry · 55d
Cleared Jun 01, 1999
FOUNDATION POROUS HIP STEM
K991226 · LZO
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 01, 1999
8MM FORGED CEMENTED STEM
K991227 · JDI
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 01, 1999
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
K991302 · IXC
Smartlight, Inc.
Radiology · 46d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d
Cleared Jun 01, 1999
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
K991641 · MVO
Phamatech
Toxicology · 20d
Cleared Jun 01, 1999
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
K991688 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Jun 01, 1999
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY...
K991707 · DHX
Beckman
Immunology · 13d
Cleared Jun 01, 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · DSY
Atrium Medical Corp.
Cardiovascular · 5d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · LSL
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared May 28, 1999
GBACT + KIT
K984141 · JBP
Sienco, Inc.
Hematology · 191d
Cleared May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · LBR
Polymer Technology Systems, Inc.
Chemistry · 122d
Cleared May 28, 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · LYY
Terang Nusa Sdn Bhd
General Hospital · 101d
Cleared May 28, 1999
DPD-12PCC
K990734 · IYE
Scanditronix Medical AB
Radiology · 84d
Cleared May 28, 1999
GC RELINE SOFT/EXTRA SOFT
K990736 · EBI
GC America, Inc.
Dental · 84d
Cleared May 28, 1999
STARDENTAL AXCS STERILE WATER SYSTEM
K990844 · EIA
Dentalez Group
Dental · 74d
Cleared May 28, 1999
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND...
K991088 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared May 28, 1999
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
K991156 · JOC
Great Smokies Diagnostic Laboratory
Chemistry · 51d
Cleared May 28, 1999
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL,...
K991158 · LYY
P. T. Tata Rubberindo Industries
General Hospital · 51d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d