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
85873–85896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1999
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
K991587 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 49d
Cleared Jun 25, 1999
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
K991610 · DDC
Zeus Scientific, Inc.
Immunology · 46d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704 · JJY
Dade Behring, Inc.
Chemistry · 37d
Cleared Jun 25, 1999
MAERSK MEDICAL CONTOUR INFUSION SET
K991759 · FPA
Maersk Medical A/S
General Hospital · 32d
Cleared Jun 25, 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 25, 1999
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
K991843 · JKA
Greiner Meditech, Inc.
Chemistry · 28d
Cleared Jun 25, 1999
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K991928 · GCJ
Allegiance Healthcare Corp.
General & Plastic Surgery · 17d
Cleared Jun 24, 1999
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS...
K984116 · FRF
Abatement Technologies, Inc.
General Hospital · 219d
Cleared Jun 24, 1999
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
K990020 · FMF
Te ME NA S.A.R.L.
General Hospital · 171d
Cleared Jun 24, 1999
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
K990325 · DKZ
Syntron Bioresearch, Inc.
Toxicology · 142d
Cleared Jun 24, 1999
MTM BIOSCANNER C TEST STRIPS
K990688 · CHH
Polymer Technology Systems, Inc.
Chemistry · 119d
Cleared Jun 24, 1999
SIEMENS INFINITY EEG POD
K991012 · OLT
Siemens Medical Solutions USA, Inc.
Neurology · 90d
Cleared Jun 24, 1999
QUANTEC-E IRRIGATION SYSTEM
K991035 · EIA
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Jun 24, 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
K991653 · FPA
Rymed Technologies, Inc.
General Hospital · 42d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775 · DXG
Mennen Medical, Inc.
Cardiovascular · 30d
Cleared Jun 24, 1999
RENEW LEAD EXTENSION
K991784 · GZB
Advanced Neuromodulation Systems
Neurology · 30d
Cleared Jun 24, 1999
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
K991891 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 21d
Cleared Jun 23, 1999
SARGON IMMEDIATE LOAD IMPLANT, MODEL D
K981141 · DZE
Sargon Ent., Inc.
Dental · 450d
Cleared Jun 23, 1999
CAPIOX CARDIOPLEGIA
K982467 · DTR
Terumo Medical Corp.
Cardiovascular · 343d
Cleared Jun 23, 1999
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K984298 · HAW
Z-Kat, Inc.
Neurology · 203d
Cleared Jun 23, 1999
LONGPORT MODEL LDS -1
K990238 · IYO
Longport, Inc.
Radiology · 149d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 99d