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
95185–95208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1997
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964492 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964495 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
SUTURE APPLICATOR
K964672 · GCJ
Laurus Medical Group
General & Plastic Surgery · 78d
Cleared Feb 07, 1997
MITRAFLEX PIGMENTED WOUND DRESSING
K964701 · FRO
Polymedica Industries, Inc.
General & Plastic Surgery · 74d
Cleared Feb 07, 1997
DELTA N95 RESPIRATOR
K964722 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
RACAL N95 RESIRATOR
K964723 · FXX
Racal Filter Technologies, Inc.
General Hospital · 74d
Cleared Feb 07, 1997
KENDALL CURITY URETERAL CATHETER
K964899 · EYB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 66d
Cleared Feb 07, 1997
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE...
K964927 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 07, 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · LYZ
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 58d
Cleared Feb 07, 1997
RUSCH SUPRAPUBIC TRAY
K970021 · KOB
Rusch, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 06, 1997
AS/3 ESTPR MODULE
K953175 · MLD
Datex Division Instrumentarium Corp.
Cardiovascular · 580d
Cleared Feb 06, 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · MQS
Cobe Renal Care, Inc.
Gastroenterology & Urology · 531d
Cleared Feb 06, 1997
METALLIC SPHERICAL CMC IMPLANT
K960534 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 365d
Cleared Feb 06, 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 356d
Cleared Feb 06, 1997
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498 · HRS
Howmedica, Inc.
Orthopedic · 294d
Cleared Feb 06, 1997
MLC FIT
K962335 · IYE
Impac Medical Systems, Inc.
Radiology · 234d
Cleared Feb 06, 1997
MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
K962603 · DQA
Masimo Corp.
Anesthesiology · 219d
Cleared Feb 06, 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 209d
Cleared Feb 06, 1997
M AND R REUSABLE ELECTRODES (MULTIPLE)
K963125 · GZJ
M & R Mfg., Inc.
Neurology · 178d
Cleared Feb 06, 1997
OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
K963139 · DDD
Olympus America, Inc.
Immunology · 178d
Cleared Feb 06, 1997
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
K963302 · ITX
Tayman Medical, Inc.
Radiology · 168d
Cleared Feb 06, 1997
TARGET MYOGLOBIN TEST
K963680 · DDR
Texas Immunology, Inc.
Immunology · 143d
Cleared Feb 06, 1997
LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
K963741 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 142d
Cleared Feb 06, 1997
SYSMEX CA-6000
K964139 · GKP
Dade Intl., Inc.
Hematology · 114d