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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
2977–3000 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 87d
Cleared Nov 14, 2003
SPIROPRO SPO2
K031515 · DQA
Viasys Healthcare GmbH
Anesthesiology · 184d
Cleared Nov 13, 2003
MONOJECT INSULIN SYRINGE
K033373 · FMI
Tyco Healthcare
General Hospital · 22d
Cleared Nov 13, 2003
NAVIGATOR I
K032879 · INI
Adaptive Healthcare Technologies, Inc.
Physical Medicine · 59d
Cleared Nov 13, 2003
HOSPITAL SPACER
K032809 · CAF
Respironics Healthscan, Inc.
Anesthesiology · 65d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR...
K032444 · LZC
Cardinalhealth
General Hospital · 97d
Cleared Nov 06, 2003
VITERION 100 TELEHEALTH MONITOR
K030419 · MWI
Viterion Telehealthcare, LLC
Cardiovascular · 269d
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388 · MYU
Cardinalhealth
Neurology · 88d
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