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
80713–80736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002870 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 33d
Cleared Oct 16, 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200...
K002922 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 27d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · KWP
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666 · JWH
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · DQO
AngioDynamics, Inc.
Cardiovascular · 144d
Cleared Oct 13, 2000
FOCUS
K002147 · MUJ
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Oct 13, 2000
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K002168 · EJI
Ronvig Instruments, Ltd.
Dental · 88d
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