FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3049–3072 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 31, 2003
MERCATOR HEALTHCARE MALE LATEX CONDOM
K031369 · HIS
Mercator Healthcare , Ltd.
Obstetrics & Gynecology · 184d
Cleared Oct 16, 2003
EASYGLUCO, MODEL IGM0002
K031501 · NBW
American Healthcare, Inc.
Chemistry · 156d
Cleared Oct 15, 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · KGO
Cardinalhealth
General Hospital · 174d
Cleared Oct 10, 2003
MODIFICATION TO HL168
K033043 · DXN
Health & Life Co., Ltd.
Cardiovascular · 11d
Cleared Oct 10, 2003
HL888BA
K032839 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
HL888BM
K032837 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
K030998 · IPF
Healthonics, Inc.
Physical Medicine · 193d
Cleared Oct 02, 2003
HL888 AF
K032913 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2003
HL888BF
K032695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · GXY
Otto Bock Healthcare LP
Neurology · 12d
Cleared Sep 15, 2003
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
K032054 · HAW
Radionics, A Division of Tyco...
Neurology · 75d
Cleared Sep 09, 2003
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K032525 · NBC
Bayer Healthcare, LLC
Chemistry · 25d
Cleared Sep 09, 2003
BLOOD PRESSURE MONITOR, MODEL KP-7000
K032492 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d
Cleared Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
K032524 · GKZ
Bayer Healthcare, LLC
Hematology · 24d
Cleared Sep 05, 2003
ENDOSCOPIC APPLICATOR
K031882 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 79d
Cleared Aug 29, 2003
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
K031697 · GEH
Schering-Plough Healthcare Products,...
General & Plastic Surgery · 88d
Cleared Aug 27, 2003
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · HIB
Kentron Health Care, Inc.
Obstetrics & Gynecology · 175d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · MEA
Baxter Healthcare Corp
General Hospital · 92d
Cleared Aug 12, 2003
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K031713 · EWO
Viasys Healthcare, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 06, 2003
TOX AMMONIA CALIBRATOR
K031683 · JIX
Bayer Healthcare, LLC
Chemistry · 68d
Cleared Aug 01, 2003
BALL RECORDING ELECTRODE/STIMULATION PROBE
K030517 · GZK
Viasys Healthcare, Inc.
Neurology · 163d
Cleared Aug 01, 2003
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
K012715 · NLF
Hygia Health Services, Inc.
Anesthesiology · 717d
Cleared Jul 31, 2003
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188 · CJM
Nichols Institute Diagnostics
Chemistry · 14d
Cleared Jul 30, 2003
SPIROSOFT
K031194 · BTY
Viasys Healthcare GmbH
Anesthesiology · 105d