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
95905–95928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1996
ETHICON ENDOSUTURE SYSTEM
K963329 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 63d
Cleared Oct 25, 1996
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
K963395 · LMB
Sectra-Imtec AB
Radiology · 58d
Cleared Oct 25, 1996
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH...
K963619 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 45d
Cleared Oct 25, 1996
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 44d
Cleared Oct 25, 1996
MEROPENEM, 10 MCG, SENSI-DISC
K963845 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 30d
Cleared Oct 24, 1996
I.V. START KIT
K950686 · FMI
James J. Schramm
General Hospital · 618d
Cleared Oct 24, 1996
PERFECTA REVISION HIP SYSTEM
K955553 · LWJ
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD...
K955882 · MKJ
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
K955923 · MKJ
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
CSF/URINE TOTAL PROTEIN
K961864 · CEK
Teco Diagnostics
Chemistry · 163d
Cleared Oct 24, 1996
EML105 ELECTROLYTE METABOLITE ANALYZER
K962334 · JGS
Radiometer America, Inc.
Chemistry · 129d
Cleared Oct 24, 1996
PERSONAL BEST II
K962929 · BZH
Healthscan Products, Inc.
Anesthesiology · 87d
Cleared Oct 24, 1996
CHECKMATE ANKLE RESTRAINT SYSTEM
K962963 · FMQ
Hollister, Inc.
General Hospital · 86d
Cleared Oct 24, 1996
HEELBO JOHNNY GRAIT BELT SECURITY BELT
K962964 · FMQ
Hollister, Inc.
General Hospital · 86d
Cleared Oct 24, 1996
ETEST FOR CEFEPIME
K963107 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Oct 24, 1996
JETLITE
K963110 · EBZ
J. Morita USA, Inc.
Dental · 73d
Cleared Oct 24, 1996
PROSTYLE COMPACT
K963209 · KLC
Planmeca Oy
Dental · 69d
Cleared Oct 24, 1996
PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
K963514 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 51d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS BUN REAGENT
K963537 · LFP
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 24, 1996
SIGMA DIAGNOSTICS CO2 ACID REAGENT
K963541 · JFL
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 24, 1996
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K963560 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d