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"
3361–3384 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089 · FMF
Baxter Healthcare Corp
General Hospital · 833d
Cleared Jul 05, 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD...
K000901 · FYA
Molnlycke Health Care, Inc.
General Hospital · 106d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Omron Healthcare, Inc.
Cardiovascular · 14d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE...
K000952 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 98d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · KKX
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Jun 23, 2000
KLINIDRAPE SURGICAL DRAPES
K000906 · KKX
Molnlycke Health Care, Inc.
General Hospital · 94d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...
K992532 · FOZ
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
K001485 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 32d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100...
K001475 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 33d
Cleared Jun 12, 2000
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
K001252 · IOR
Maxhealth Corp.
Physical Medicine · 54d
Cleared Jun 09, 2000
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
K000377 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared May 18, 2000
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · FMI
Pro. Duct Health, Inc.
Pathology · 44d
Cleared May 16, 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS...
K000303 · JOW
Healthcare Service and Supply
Cardiovascular · 105d
Cleared May 09, 2000
POWDER FREE STERILE LATEX EXAMINATION GLOVES
K001141 · LYY
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared May 03, 2000
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF...
K000745 · LYY
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Apr 28, 2000
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
K993756 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 175d
Cleared Apr 21, 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · FRG
Allegiance Healthcare Corp.
General Hospital · 158d