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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
6193–6216 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 19, 2005
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K051182 · MSH
Inovel, LLC
General Hospital · 10d
Cleared May 19, 2005
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST...
K051079 · MRZ
Hospicare, Inc.
General Hospital · 22d
Cleared May 19, 2005
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
K050528 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 78d
Cleared May 18, 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051153 · LYZ
Hebei Manful Import & Export Co., Ltd.
General Hospital · 14d
Cleared May 18, 2005
STRYKER DISCMONITOR
K050753 · FMF
Stryker Instruments
General Hospital · 56d
Cleared May 17, 2005
MICROTEK EQUIPMENT DRAPES
K050322 · KKX
Microtek Medical, Inc.
General Hospital · 97d
Cleared May 12, 2005
MINILOC SAFETY INFUSION SET
K050600 · FPA
Specialized Health Products, Intl.
General Hospital · 64d
Cleared May 12, 2005
STERRAD NX CHALLENGE PACK
K042450 · FRC
Advanced Sterilization Products
General Hospital · 245d
Cleared May 11, 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · FLL
Microlife Intellectual Property GmbH
General Hospital · 12d
Cleared May 11, 2005
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
K050464 · FMI
Ultimed, Inc.
General Hospital · 77d
Cleared May 11, 2005
MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
K050071 · KGO
H.B.M. USA Co.,Inc.
General Hospital · 119d
Cleared May 11, 2005
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
K041984 · MED
Best Sanitizers, Inc.
General Hospital · 292d
Cleared May 10, 2005
PAINPUMP2
K043466 · FRN
Stryker Instruments
General Hospital · 146d
Cleared May 10, 2005
LASIK EYE DRAPE
K042977 · KKX
Odyssey Medical, Inc.
General Hospital · 194d
Cleared May 10, 2005
MARINA MEDICAL FINGER PROTECTORS
K042534 · KGO
Marina Medical Instruments, Inc.
General Hospital · 235d
Cleared May 09, 2005
BARRIER SURGICAL GOWNS
K050786 · FYA
Molnlycke Health Care
General Hospital · 42d
Cleared May 09, 2005
AMIGO INSULIN PUMP
K050312 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 90d
Cleared May 09, 2005
UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
K050116 · MEG
Uniqsafe Biomeditech Co., Ltd.
General Hospital · 111d
Cleared May 05, 2005
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · FYA
Standard Textile Co., Inc.
General Hospital · 331d
Cleared May 05, 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · MED
Healthpoint, Ltd.
General Hospital · 349d
Cleared May 04, 2005
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE
K040916 · LYZ
Vitalcare Group, Inc.
General Hospital · 391d
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495 · FMF
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared Apr 28, 2005
COMPEL SURGICAL GOWNS
K041539 · FYA
Standard Textile Co., Inc.
General Hospital · 324d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · FLL
Ge Healthcare
General Hospital · 26d