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
85345–85368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · MXJ
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · LGC
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988...
K984508 · DZA
W&H Dentalwerk Buermoos GmbH
Dental · 189d
Cleared Jun 25, 1999
INDEPENDENCE 624
K990122 · ITI
Eagle Parts & Products, Inc.
Physical Medicine · 163d
Cleared Jun 25, 1999
INDEPENDENCE 324
K990484 · ITI
Eagle Parts & Products, Inc.
Physical Medicine · 129d
Cleared Jun 25, 1999
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · QEZ
Cordis Corp.
Cardiovascular · 108d
Cleared Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 25, 1999
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
K991053 · DZE
Astra Tech, Inc.
Dental · 87d
Cleared Jun 25, 1999
FRAMELESS NEUROMATE
K991081 · HAW
Integrated Surgical Systems, Inc.
Neurology · 86d
Cleared Jun 25, 1999
ARROW FWD POWER WHEELCHAIR
K991168 · ITI
Invacare Corp.
Physical Medicine · 79d
Cleared Jun 25, 1999
FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
K991257 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 73d
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325 · LPH
Encore Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 25, 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
K991366 · KNW
Daum GmbH
Gastroenterology & Urology · 66d
Cleared Jun 25, 1999
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
K991444 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 60d
Cleared Jun 25, 1999
ORTHOSLICE OS1000 SERIES
K991455 · EHD
Trophy Radiologie
Radiology · 60d
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