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"
2977–3000 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
K042234 · FPA
Specialty Health Products, Inc.
General Hospital · 21d
Cleared Sep 01, 2004
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
K031370 · CAF
Shining World Health Care Co., Ltd.
Anesthesiology · 490d
Cleared Aug 31, 2004
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
K042273 · DXN
Health Hero Network, Inc.
Cardiovascular · 8d
Cleared Aug 31, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
K042265 · DXN
Health & Life Co., Ltd.
Cardiovascular · 8d
Cleared Aug 31, 2004
HC604 CPAP HUMIDIFIER
K041900 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 48d
Cleared Aug 27, 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997 · MUJ
Radionics, A Division of Tyco...
Radiology · 32d
Cleared Aug 27, 2004
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · LFD
Glaxosmithkline Consumer Healthcare,...
Dental · 78d
Cleared Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
K041428 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Aug 27, 2004
MYOHEALTH CLENCHING INHIBITOR
K040315 · MQC
Mci-Myohealth Systems
Dental · 200d
Cleared Aug 20, 2004
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K041359 · GZJ
Body Clock Health Care, Ltd.
Neurology · 91d
Cleared Aug 20, 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 100d
Cleared Aug 12, 2004
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
K042022 · DXH
Datrix, Inc. Dba of Jon Barron, Inc.
Cardiovascular · 15d
Cleared Aug 12, 2004
SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
K033027 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 321d
Cleared Jul 20, 2004
DOVER ROB-NEL CATHETER
K040897 · KOD
Tyco Healthcare
Gastroenterology & Urology · 105d
Cleared Jul 19, 2004
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K041816 · DRG
Rtx Healthcare A/S
Cardiovascular · 13d
Cleared Jul 19, 2004
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
K033897 · ECX
Aga-Linde Health Care
Anesthesiology · 216d
Cleared Jul 15, 2004
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · JOW
Tyco Healthcare
Cardiovascular · 126d
Cleared Jul 09, 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · FRN
Baxter Healthcare Corporation
General Hospital · 11d
Cleared Jul 07, 2004
DOVER RED RUBBER ROBINSON CATHETER
K041243 · KOD
Tyco Healthcare
Gastroenterology & Urology · 57d
Cleared Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · CDD
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Jul 02, 2004
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K040416 · JEQ
Philips Oral Healthcare, Inc.
Dental · 135d
Cleared Jun 30, 2004
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K041686 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 8d
Cleared Jun 30, 2004
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET...
K032438 · NGT
Tyco Healthcare
General Hospital · 328d
Cleared Jun 28, 2004
SCD EXPRESS PORTABLE COMPRESSION SYSTEM
K040511 · JOW
Tyco Healthcare/Kendall
Cardiovascular · 122d