Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81841–81864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · FMI
Sterling Medivations, Inc.
General Hospital · 86d
Cleared Oct 13, 2000
BVI SLING
K002233 · PAJ
Bio-Vascular, Inc.
Obstetrics & Gynecology · 81d
Cleared Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
K002396 · KOD
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 13, 2000
COALIZA PROTEIN S-FREE
K002467 · GGP
Instrumentation Laboratory CO
Hematology · 63d
Cleared Oct 13, 2000
PACIFIER THERMOMETER MODELS VT-901F, VT901C
K002562 · FLL
Valeo Corp.
General Hospital · 57d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · DCK
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Oct 13, 2000
XIA SPINE SYSTEM
K002858 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Oct 13, 2000
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · HCH
Aesculap, Inc.
Neurology · 29d
Cleared Oct 13, 2000
HL168B
K002882 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Oct 13, 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 13, 2000
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
K002909 · FRO
Acrymed, Inc.
General & Plastic Surgery · 25d
Cleared Oct 13, 2000
AERONEB PORTABLE NEBULIZER
K003022 · CAF
Aerogen, Inc.
Anesthesiology · 15d
Cleared Oct 13, 2000
AUTOSTAT II ENA-6 PROFILE ELISA
K003054 · LLL
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared Oct 13, 2000
AUTOSTAT II ENA-4 PROFILE ELISA
K003057 · LLL
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared Oct 13, 2000
SAFE MINI
K980974 · DTZ
Polystan A/S
Cardiovascular · 942d
Cleared Oct 13, 2000
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
K994059 · CAZ
Hdc Corp.
Anesthesiology · 319d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · FGE
Guidant Corp.
Gastroenterology & Urology · 87d
Cleared Oct 12, 2000
CARRIAZO BARRAQUER II MICROKERATOME
K002191 · HMY
Moria, Inc.
Ophthalmic · 84d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 41d
Cleared Oct 12, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 37d
Cleared Oct 12, 2000
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
K002855 · JGS
Biocare Corp.
Chemistry · 29d
Cleared Oct 12, 2000
INVERNESS MEDICAL OVULATION PREDICTOR TEST
K002867 · CEP
Selfcare, Inc.
Chemistry · 29d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 15d