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"
2593–2616 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 14, 2007
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
K070685 · FRO
Tyco Healthcare
General & Plastic Surgery · 186d
Cleared Sep 12, 2007
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
K070653 · FRO
Tyco Healthcare
General & Plastic Surgery · 187d
Cleared Sep 11, 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 82d
Cleared Sep 11, 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 105d
Cleared Sep 10, 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 95d
Cleared Sep 10, 2007
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT...
K071414 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 112d
Cleared Aug 31, 2007
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
K071299 · NFJ
Digital Healthcare, Ltd.
Ophthalmic · 114d
Cleared Aug 31, 2007
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION...
K070630 · FPA
Health Line International Corporation...
General Hospital · 177d
Cleared Aug 17, 2007
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
K070036 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 17, 2007
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
K070034 · NQG
Ascent Healthcare Solutions
Cardiovascular · 226d
Cleared Aug 14, 2007
MASTERSCREEN PNEUMO & MASTERSCOPE
K071753 · BTY
Viasys Healthcare GmbH
Anesthesiology · 47d
Cleared Aug 10, 2007
AIRLIFE NEBULIZER CAP
K072119 · CAF
Cardinalhealth
Anesthesiology · 9d
Cleared Aug 08, 2007
RTX3370
K071953 · DRG
Rtx Healthcare A/S
Cardiovascular · 23d
Cleared Aug 06, 2007
LULLABY
K071828 · LBI
Ge Healthcare Clinical Systems
General Hospital · 34d
Cleared Jul 30, 2007
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
K071972 · LLZ
Agfa Healthcare Corp.
Radiology · 13d
Cleared Jul 27, 2007
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
K063757 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 220d
Cleared Jul 26, 2007
PSI BANDS
K070766 · MVV
Psi Health Solutions, Inc.
Neurology · 128d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · FMZ
Ge Healthcare
General Hospital · 81d
Cleared Jul 13, 2007
MEPILEX AG DRESSING
K071354 · FRO
Monlycke Health Care
General & Plastic Surgery · 59d
Cleared Jul 13, 2007
AUTOVENT 4000 WITH CPAP
K070636 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 128d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · MWI
Omron Healthcare, Inc.
Cardiovascular · 17d
Cleared Jun 29, 2007
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · MLO
Medick Healthcare , Ltd.
Cardiovascular · 235d
Cleared Jun 22, 2007
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
K071297 · LLZ
Agfa Healthcare Corp.
Radiology · 44d
Cleared Jun 22, 2007
TRIFLEX SELECT
K070647 · KGO
Cardinal Health, Inc.
General Hospital · 106d