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
81241–81264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 11, 2000
NARKOMAT, MODEL 2000
K000995 · BSZ
Heyer America, Inc.
Anesthesiology · 197d
Cleared Oct 11, 2000
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K001835 · INI
Trac About, Inc.
Physical Medicine · 117d
Cleared Oct 11, 2000
PINS AND WIRES
K002125 · HTY
Implant Resource, Inc.
Orthopedic · 89d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 11, 2000
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED...
K002318 · INO
United Chair Mfg., LLC
Physical Medicine · 72d
Cleared Oct 11, 2000
SURGI-VISION URETHRAL COIL
K002345 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
K002669 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d