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
6769–6792 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 29, 2003
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K031647 · JOJ
Getinge USA, Inc.
General Hospital · 63d
Cleared Jul 29, 2003
MIX2VIAL TRANSFER DEVICE
K031861 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 43d
Cleared Jul 28, 2003
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50...
K032007 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 28d
Cleared Jul 25, 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · FMF
American Syringe Company
General Hospital · 84d
Cleared Jul 25, 2003
EXCEL PRIMARY SOLUTION SET
K031500 · FPA
Exelint Intl. Co.
General Hospital · 73d
Cleared Jul 25, 2003
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
K031580 · LZA
Green Prospect Sdn Bhd
General Hospital · 66d
Cleared Jul 25, 2003
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
K031854 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 39d
Cleared Jul 25, 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS,...
K032147 · FRN
Alaris Medical Systems, Inc.
General Hospital · 11d
Cleared Jul 24, 2003
MEGATECH SCIENTIFIC FACE MASK
K030239 · FXX
Megatech Scientific Pte, Ltd.
General Hospital · 182d
Cleared Jul 24, 2003
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE...
K031581 · LYY
Green Prospect Sdn Bhd
General Hospital · 65d
Cleared Jul 23, 2003
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
K031390 · LGZ
Minimed, Inc.
General Hospital · 82d
Cleared Jul 21, 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · FRN
Stryker Instruments
General Hospital · 94d
Cleared Jul 15, 2003
B. BRAUN NERVE BLOCK CATHETER
K030830 · MEB
B.Braun Medical, Inc.
General Hospital · 123d
Cleared Jul 15, 2003
DBC PRESS ACUPUNCTURE NEEDLES
K031250 · MQX
Lhasa Medical, Inc.
General Hospital · 87d
Cleared Jul 15, 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
K031844 · LJT
Boston Scientific Corp
General Hospital · 29d
Cleared Jul 14, 2003
SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
K024007 · FOZ
Sunder Biomedical Tech. Co., Ltd.
General Hospital · 222d
Cleared Jul 14, 2003
VAXCEL WITH PASV PORT, MODEL 45-213
K032008 · LJT
Boston Scientific Corp
General Hospital · 14d
Cleared Jul 11, 2003
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
K031060 · MQX
Lhasa Medical, Inc.
General Hospital · 99d
Cleared Jul 11, 2003
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · FPK
Medrad, Inc.
General Hospital · 29d
Cleared Jul 10, 2003
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · MQX
Asia-Med GmbH and CO KG
General Hospital · 37d
Cleared Jul 10, 2003
X-PROT DUO PORT
K032044 · LJT
C.R. Bard, Inc.
General Hospital · 8d
Cleared Jul 09, 2003
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · LZH
Zevex Intl., Inc.
General Hospital · 86d
Cleared Jul 09, 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 19d
Cleared Jul 08, 2003
SEZ SAFETY SYRINGE
K031163 · MEG
Sez Corporation
General Hospital · 85d