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
4465–4488 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 06, 2011
BEHIND EAR GENTLE TOUCH THERMOMETER
K103839 · FLL
Kaz, Inc.
General Hospital · 158d
Cleared Jun 06, 2011
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK...
K103210 · FRG
Advanced Sterilization Products
General Hospital · 217d
Cleared Jun 06, 2011
BLUE POWDERFREE NITRILE EXAMINATION GLOVE
K102623 · LZA
Pt. Medisafe Technologies
General Hospital · 266d
Cleared Jun 06, 2011
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K101733 · GCJ
Sac, LLC Dba Pinnacle Medical Surgical
General Hospital · 350d
Cleared Jun 03, 2011
AMSCO WARMING CABINET
K110769 · LGZ
STERIS Corporation
General Hospital · 77d
Cleared May 27, 2011
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818...
K102935 · FLL
Kingtech Enterprise, Ltd.
General Hospital · 235d
Cleared May 27, 2011
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
K100895 · LYY
Dipped Products Limited
General Hospital · 422d
Cleared May 26, 2011
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM...
K101128 · OUK
Filligent Limited
General Hospital · 399d
Cleared May 25, 2011
CLASSIX CHEMICAL STERILIZATION INDICATOR
K102894 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 237d
Cleared May 23, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110155 · LZA
Tangshan Xiangrui Plastic Products...
General Hospital · 124d
Cleared May 20, 2011
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · LGZ
Emit Corporation
General Hospital · 143d
Cleared May 20, 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · KCT
Gyrus Acmi, Inc.
General Hospital · 226d
Cleared May 20, 2011
RMS SUBCUTANEOUS NEEDLE SET
K102512 · FPA
Repro-Med Systems, Inc.
General Hospital · 261d
Cleared May 20, 2011
ABS BLOWER, ABS NOZZLE, MODEL 1001
K092801 · ORC
Nimbic Systems, LLC
General Hospital · 616d
Cleared May 13, 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771 · FMF
Becton, Dickinson and Company
General Hospital · 53d
Cleared May 13, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110146 · LZA
Tangshan Kaiyue Glove Co., Ltd.
General Hospital · 115d
Cleared May 13, 2011
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS...
K110102 · LZA
Preventive Care, Inc.
General Hospital · 120d
Cleared May 13, 2011
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
K103589 · LBI
Natus Medical Incorporated
General Hospital · 157d
Cleared May 13, 2011
COTRONIC DIGITAL THERMOMETER
K103407 · FLL
Cotronic Manufacturing
General Hospital · 175d
Cleared May 13, 2011
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
K102328 · FMI
Shandong Weigao Group Medical Polymer...
General Hospital · 269d
Cleared May 11, 2011
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH...
K103525 · FPL
International Biomedical, Ltd.
General Hospital · 161d
Cleared May 11, 2011
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH...
K103523 · FPL
International Biomedical, Ltd.
General Hospital · 161d
Cleared May 10, 2011
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
K110314 · LYZ
True Glove Factory
General Hospital · 97d
Cleared May 10, 2011
DYNACOR LUBRICATION GEL
K103718 · KMJ
Medline Industries, Inc.
General Hospital · 140d