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"
2881–2904 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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 13, 2005
PROTEGE ULTRASONIC INSERT
K051776 · ELC
Discus Dental, Inc.
Dental · 12d
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
Cleared Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · CJM
Nichols Institute Diagnostics
Chemistry · 65d
Cleared May 26, 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · LBS
Bayer Healthcare, LLC
Chemistry · 78d
Cleared May 25, 2005
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX,...
K051092 · CCL
Ge Healthcare
Anesthesiology · 27d
Cleared May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 44d
Cleared May 19, 2005
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · MSH
Inovel, LLC
General Hospital · 10d
Cleared May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
K051072 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 16d
Cleared May 12, 2005
MINILOC SAFETY INFUSION SET
K050600 · FPA
Specialized Health Products, Intl.
General Hospital · 64d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518 · NDN
Cardinalhealth
Orthopedic · 142d
Cleared May 10, 2005
PIONEER U121 SERIES CPAP
K041823 · BZD
Merits Health Products Co., Ltd.
Anesthesiology · 308d
Cleared May 09, 2005
BARRIER SURGICAL GOWNS
K050786 · FYA
Molnlycke Health Care
General Hospital · 42d
Cleared May 06, 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · OLW
Ge Healthcare
Neurology · 35d
Cleared May 05, 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · MED
Healthpoint, Ltd.
General Hospital · 349d