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

5,282 results for "health"
2761–2784 of 5,282
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 26, 2006
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
K061285 · FPA
Cardinal Health, Alaris Products
General Hospital · 79d
Cleared Jul 24, 2006
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · CAF
Merits Health Products Co., Ltd.
Anesthesiology · 221d
Cleared Jul 12, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
K061859 · MSH
Inovel, LLC
General Hospital · 12d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139 · JIT
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
ADVIA IMS CPSA CONTROL
K061137 · JJY
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jun 26, 2006
AUTOBONE2
K061625 · JAK
Ge Healthcare
Radiology · 14d
Cleared Jun 26, 2006
RANGER IRRIGATION FLUID WARMING SYSTEM
K060939 · LGZ
Arizant Healthcare, Inc.
General Hospital · 81d
Cleared Jun 23, 2006
FULLCARD ANALYSIS
K061587 · KPS
Ge Healthcare
Radiology · 15d
Cleared Jun 23, 2006
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
K060509 · NYU
Tyco Healthcare Group
Gastroenterology & Urology · 116d
Cleared Jun 21, 2006
SMDIE DEVICE INTERFACING SYSTEM
K061590 · MWI
Siemens Medical Solutions Health...
Cardiovascular · 13d
Cleared Jun 09, 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · DPS
Omron Healthcare, Inc.
Cardiovascular · 79d
Cleared Jun 05, 2006
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND...
K061308 · FYA
Cardinal Health 200, Inc.
General Hospital · 26d
Cleared Jun 05, 2006
GLUCOPACK
K052469 · NBW
Healthpia America Corp.
Chemistry · 270d
Cleared May 31, 2006
AUTO SUTUR ENDO GIA STAPLERS
K061095 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared May 31, 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · FPA
Health Line International Corporation
General Hospital · 107d
Cleared May 30, 2006
CENTRICITY AW SUITE OPTION
K061372 · LLZ
Ge Healthcare Information Technologies
Radiology · 13d
Cleared May 30, 2006
CARDIQ FUSION
K061370 · JAK
Ge Healthcare
Radiology · 13d
Cleared May 25, 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · CAF
Omron Healthcare, Inc.
Anesthesiology · 62d
Cleared May 24, 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K053539 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 155d
Cleared May 23, 2006
FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL...
K061010 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 41d
Cleared May 22, 2006
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
K060649 · FLL
Tyco Healthcare Group LP
General Hospital · 70d
Cleared May 19, 2006
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
K060240 · FLL
K-Jump Health Co., Ltd.
General Hospital · 108d
Cleared May 16, 2006
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K053230 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 179d
Cleared May 15, 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A...
K061185 · MHX
Ge Healthcare
Cardiovascular · 17d