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"
2545–2568 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Ge Healthcare
Radiology · 21d
Cleared May 05, 2008
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
K081066 · IWG
Medi-Physics, Inc., Dba GE Healthcare
Radiology · 20d
Cleared May 05, 2008
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH...
K080898 · GDW
Tyco Healthcare Group LP
General & Plastic Surgery · 35d
Cleared Apr 30, 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · JCX
Cardinalhealth
General & Plastic Surgery · 35d
Cleared Apr 22, 2008
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
K072061 · JEH
Viasys Healthcare GmbH
Anesthesiology · 270d
Cleared Apr 11, 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · DPS
Medtechs, LLC
Cardiovascular · 11d
Cleared Apr 10, 2008
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524 · MQX
Tcm World, Inc.
General Hospital · 311d
Cleared Apr 08, 2008
TRICOS T RESORBABLE BONE SUBSTITUTE
K073571 · LYC
Baxter Healthcare Corporation
Dental · 110d
Cleared Mar 31, 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 91d
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · OLW
Ge Healthcare
Neurology · 631d
Cleared Mar 11, 2008
KFH ENERGY, MODEL: E1
K073008 · GZJ
Kingfisher Healthcare NV
Neurology · 139d
Cleared Mar 06, 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 210d
Cleared Mar 06, 2008
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
K072163 · CAF
3A Health Care S.R.L.
Anesthesiology · 213d
Cleared Mar 06, 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 349d
Cleared Feb 26, 2008
1500 PRO
K080289 · DXN
Omron Healthcare, Inc.
Cardiovascular · 22d
Cleared Feb 06, 2008
MERITS E600 SERIES STAIR LIFT
K073110 · ILK
Merits Health Products Co., Ltd.
Physical Medicine · 93d
Cleared Feb 05, 2008
MODIFICATION TO:HEALTH BUDDY APPLIANCE
K080091 · DRG
Health Hero Network, Inc.
Cardiovascular · 22d
Cleared Jan 31, 2008
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 83d
Cleared Jan 25, 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · DPS
Ge Healthcare Systems Information...
Cardiovascular · 30d
Cleared Jan 25, 2008
SAFESTEP MAX POWER-INJECTABLE INFUSION SET
K073050 · FPA
Specialized Health Products...
General Hospital · 88d
Cleared Jan 17, 2008
REGISTRATION AND FUSION
K080013 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Jan 14, 2008
MERITS E700 PORCE LIFT
K073513 · ING
Merits Health Products Co., Ltd.
Physical Medicine · 31d
Cleared Jan 14, 2008
START JUNIOR
K073512 · IOR
Otto Bock Healthcare LP
Physical Medicine · 31d