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"
2809–2832 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · OLW
Ge Healthcare
Neurology · 15d
Cleared Aug 22, 2005
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
K051947 · LFL
Radionics, A Division of Tyco...
General & Plastic Surgery · 35d
Cleared Aug 17, 2005
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING...
K051793 · KGO
Ansell Healthcare Products, LLC
General Hospital · 47d
Cleared Aug 15, 2005
VCS S3T
K051131 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 104d
Cleared Aug 12, 2005
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121,...
K051370 · JOL
Baxter Healthcare Corp
General Hospital · 78d
Cleared Aug 09, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · KPR
Ge Healthcare
Radiology · 20d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG...
K051883 · OLT
Ge Healthcare
Neurology · 24d
Cleared Aug 04, 2005
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
K050430 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 167d
Cleared Aug 03, 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994 · BZD
Cardinalhealth
Anesthesiology · 106d
Cleared Aug 01, 2005
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · JIX
Bayer Healthcare, LLC
Chemistry · 45d
Cleared Aug 01, 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 110d
Cleared Jul 22, 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 58d
Cleared Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634 · MSX
Ge Healthcare
Cardiovascular · 29d
Cleared Jul 15, 2005
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
K051635 · KOI
Ge Healthcare
Anesthesiology · 25d
Cleared Jul 15, 2005
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE...
K051253 · MEA
Baxter Healthcare Corp
General Hospital · 60d
Cleared Jul 14, 2005
BARRIER SURGICAL DRAPES
K051625 · KKX
Molnlycke Health Care, Inc.
General Hospital · 24d
Cleared Jul 07, 2005
LANDLEX MODEL S400X
K050793 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 101d
Cleared Jul 07, 2005
SMARTECH, MODEL HOLI I
K050507 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 129d
Cleared Jun 24, 2005
BPCALIBRATOR MC3000/MC3100
K051546 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 11d
Cleared Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · FLL
Omron Healthcare, Inc.
General Hospital · 39d
Cleared Jun 15, 2005
ADVIA IMS LITHIUM ASSAY
K050374 · NDW
Bayer Healthcare, LLC
Chemistry · 121d
Cleared Jun 13, 2005
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K051265 · NBC
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Jun 08, 2005
REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
K051470 · DRG
Bl Healthcare, Inc.
Cardiovascular · 5d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · GAW
United States Surgical, A Division of...
General & Plastic Surgery · 47d