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"
2929–2952 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jun 25, 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · FRN
Baxter Healthcare Corp
General Hospital · 50d
Cleared Jun 22, 2004
GE DISCOVERY ST
K041543 · KPS
Ge Healthcare
Radiology · 14d
Cleared Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K040425 · NBC
Bayer Healthcare, LLC
Chemistry · 117d
Cleared Jun 10, 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · CAF
Cardinalhealth
Anesthesiology · 14d
Cleared Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 59d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared May 28, 2004
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · LCO
Akers Laboratories, Inc.
Hematology · 112d
Cleared May 27, 2004
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND...
K040512 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared May 19, 2004
BONE CEMENT FOR CRANIOPLASTY
K040152 · GXP
Cardinalhealth
Neurology · 117d
Cleared May 07, 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · LZC
Cardinalhealth
General Hospital · 155d
Cleared May 05, 2004
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
K040506 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 68d
Cleared May 05, 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · LZH
Tyco Healthcare/Kendall
General Hospital · 97d
Cleared Apr 29, 2004
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · FRO
Tyco Healthcare
General & Plastic Surgery · 182d
Cleared Apr 27, 2004
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING
K033905 · KGO
Cardinalhealth
General Hospital · 132d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 13d