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
3745–3768 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133059 · FMI
Wenzhou Beipu Science & Technology...
General Hospital · 151d
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133058 · FMI
Wenzhou Wuzhou Import & Export Co., Ltd.
General Hospital · 151d
Cleared Feb 21, 2014
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
K132457 · FLL
Biocare Asia Corporation , Ltd.
General Hospital · 199d
Cleared Feb 20, 2014
JMS SYRINGE
K132321 · FMF
JMS North America Corporation
General Hospital · 210d
Cleared Feb 20, 2014
INFANT PHOTOTHERAPY BILITRON SKY 5006
K131196 · LBI
Fanem Lda
General Hospital · 300d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K130891 · LYZ
Friend Plastic Co., Ltd.
General Hospital · 323d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130809 · LYZ
Jewel Plastic Co., Ltd.
General Hospital · 330d
Cleared Feb 18, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130800 · LYZ
Kaixuan Plastic Co., Ltd.
General Hospital · 333d
Cleared Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136 · FOZ
Nipro Medical Corporation
General Hospital · 28d
Cleared Feb 14, 2014
POWERPORT IMPLANTABLE PORT
K133335 · LJT
C.R. Bard, Inc.
General Hospital · 108d
Cleared Feb 12, 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154 · LZH
Zevex, Inc.
General Hospital · 294d
Cleared Feb 12, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K131033 · LYZ
Decent Plastic Co., Ltd.
General Hospital · 306d
Cleared Feb 12, 2014
POWDER FREE LATEX EXAMINATION GLOVES
K123537 · LYY
Qube Medical Product Sdn Bhd
General Hospital · 453d
Cleared Feb 11, 2014
DANA REUSABLE TEST PACK
K133267 · FRC
Dana Products, Inc.
General Hospital · 110d
Cleared Feb 11, 2014
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K132583 · FMI
Vidacare Corporation
General Hospital · 179d
Cleared Feb 07, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130807 · LYZ
Hope Plastic Co., Ltd.
General Hospital · 319d
Cleared Feb 06, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131341 · LYZ
Shijiazhuang Winful Plastic Co., Ltd.
General Hospital · 273d
Cleared Feb 06, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130890 · LYZ
Air Plastic Co., Ltd.
General Hospital · 311d
Cleared Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867 · FPA
Terumo Europe N.V.
General Hospital · 47d
Cleared Feb 05, 2014
RT016 INSPIRATORY FILTER
K133666 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 68d
Cleared Feb 04, 2014
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
K132140 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 208d
Cleared Feb 04, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130582 · LYZ
Heze City Green Food Co., Ltd.
General Hospital · 336d
Cleared Feb 03, 2014
MEDLINE SHARPS CONTAINER
K132767 · MMK
Medline Industries, Inc.
General Hospital · 152d
Cleared Feb 03, 2014
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · MEB
I-Flow, LLC
General Hospital · 278d