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
6625–6648 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 22, 2003
VINYL EXAMINATION GLOVES, POWDERED
K033308 · LYZ
Tangshan Transocean Plastic Products...
General Hospital · 69d
Cleared Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
K031373 · LZG
Insulet Corp.
General Hospital · 233d
Cleared Dec 17, 2003
SET GRI-FILL 2.0-1 WAY
K033682 · LHI
Laboratorios Grifols, S.A.
General Hospital · 23d
Cleared Dec 17, 2003
(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
K033229 · LYZ
Bernard Technologies, Inc.
General Hospital · 72d
Cleared Dec 17, 2003
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
K033040 · FMT
International Hospital Supply Co.
General Hospital · 79d
Cleared Dec 17, 2003
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 86d
Cleared Dec 16, 2003
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
K033054 · MEA
Harvard Clinical Technology
General Hospital · 78d
Cleared Dec 12, 2003
KACEY INSULIN SYRINGE
K033166 · FMF
Kacey, Inc.
General Hospital · 73d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE,...
K033576 · FPA
Abbott Laboratories
General Hospital · 21d
Cleared Dec 04, 2003
UP-GRADE FOREHEAD THERMOMETER
K032362 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692 · FPA
Icu Medical, Inc.
General Hospital · 561d
Cleared Dec 03, 2003
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
K033082 · FLL
Metatech Co., Ltd.
General Hospital · 65d
Cleared Dec 03, 2003
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
K031818 · MQX
Facilai Enterprises , Ltd.
General Hospital · 174d
Cleared Nov 28, 2003
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND...
K032716 · CAH
Portex , Ltd.
General Hospital · 87d
Cleared Nov 24, 2003
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · KPE
Laboratorios Grifols, S.A.
General Hospital · 203d
Cleared Nov 21, 2003
LMT NOMAG IC 1,5
K033565 · FPL
Lmt Lammers Medical Technology GmbH
General Hospital · 9d
Cleared Nov 20, 2003
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057 · FYA
Deroyal
General Hospital · 52d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50...
K032940 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150...
K032938 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 59d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032908 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032907 · LYZ
Shijiazhuang Fuguan Plastic Products...
General Hospital · 64d
Cleared Nov 20, 2003
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING...
K023537 · LYY
Sgmp Co., Ltd.
General Hospital · 395d
Cleared Nov 20, 2003
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E
K023452 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 401d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · LJT
Horizon Medical Products, Inc.
General Hospital · 15d