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

5,280 results for "health"
2641–2664 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH...
K072576 · FPA
Baxter Healthcare Corp
General Hospital · 54d
Cleared Oct 25, 2007
DRYSTAR AXYS, MODEL EYZ4E
K072680 · LMC
Agfa Healthcare Corporation
Radiology · 31d
Cleared Oct 16, 2007
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K071049 · EZL
Tyco Healthcare
Gastroenterology & Urology · 186d
Cleared Oct 15, 2007
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 298d
Cleared Oct 10, 2007
MASTERSCREEN & OXYCON CPX
K072323 · BZC
Viasys Healthcare GmbH
Anesthesiology · 51d
Cleared Oct 10, 2007
NAVIGATOR APPLICATIONS SUITE
K071097 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 175d
Cleared Oct 02, 2007
REPROCESSED TROCARS
K070059 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 270d
Cleared Sep 28, 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 78d
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