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
82321–82344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2000
SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE...
K000876 · MNI
Interpore Cross Intl.
Orthopedic · 29d
Cleared Apr 18, 2000
PARA 12 PLUS RETICS
K000945 · GLQ
Streck Laboratories, Inc.
Hematology · 26d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 21d
Cleared Apr 18, 2000
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
K001154 · JGS
I-Stat Corp.
Chemistry · 8d
Cleared Apr 18, 2000
NUVASIVE TOWNLEY FACET SCREW
K994308 · MRW
Nuvasive, Inc.
Orthopedic · 119d
Cleared Apr 17, 2000
DRG AURICA ELISA TESTOSTERONE KIT
K000043 · CDZ
Drg Intl., Inc.
Chemistry · 102d
Cleared Apr 17, 2000
ENHANCED COMPENSATING FILTER
K000137 · IXI
Computerized Medical Systems, Inc.
Radiology · 90d
Cleared Apr 17, 2000
FLUROPERM 60-OK, PARAGON HDS-OK
K000224 · MUW
Paragon Vision Sciences
Ophthalmic · 84d
Cleared Apr 17, 2000
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
K000398 · GGP
Shield Diagnostics, Ltd.
Hematology · 70d
Cleared Apr 17, 2000
RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
K000406 · BXQ
Rhino Metrics A/S
Anesthesiology · 70d
Cleared Apr 17, 2000
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · JXM
Dade Behring, Inc.
Toxicology · 66d
Cleared Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
K000603 · JHO
Helena Laboratories
Chemistry · 54d
Cleared Apr 17, 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895 · JGS
Nova Biomedical Corp.
Chemistry · 28d
Cleared Apr 17, 2000
WILSON-COOK COLONIC Z-STENT
K990034 · MQR
Med Institute, Inc.
Gastroenterology & Urology · 467d
Cleared Apr 17, 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · MGQ
Medline Industries, Inc.
General & Plastic Surgery · 329d
Cleared Apr 17, 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044,...
K991818 · FRO
Acrymed, Inc.
General & Plastic Surgery · 326d
Cleared Apr 17, 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · FJI
Idemsa
Gastroenterology & Urology · 315d
Cleared Apr 17, 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · DWF
Medtronic Vascular
Cardiovascular · 168d
Cleared Apr 17, 2000
SUTUREGROOVE
K994289 · MML
Iop, Inc.
Ophthalmic · 118d
Cleared Apr 14, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO...
K000126 · DQA
Masimo Corp.
Anesthesiology · 87d
Cleared Apr 14, 2000
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K000223 · LZA
Phoenix Medical Technology, Inc.
General Hospital · 81d
Cleared Apr 14, 2000
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
K000238 · LGC
Mrl Diagnostics
Microbiology · 78d
Cleared Apr 14, 2000
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
K000241 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 78d
Cleared Apr 14, 2000
LAZERSMILE, LAZERWHITE
K000290 · EFW
Biolase Technology, Inc.
Dental · 74d