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
8665–8688 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 16, 1998
BRAUN PREFILLED SYRINGE
K970736 · FOZ
B.Braun Medical, Inc.
General Hospital · 656d
Cleared Dec 16, 1998
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
K983073 · FPA
Integra Biotechnical, LLC
General Hospital · 105d
Cleared Dec 16, 1998
PAIN CARE 2000
K983454 · MEB
Breg, Inc.
General Hospital · 77d
Cleared Dec 14, 1998
LATEX POWDER FREE EXAMINATION GLOVES
K981942 · LYY
Maika Rubber Products Sdn Bhd
General Hospital · 195d
Cleared Dec 14, 1998
ESP7 VENOUS IMAGE
K982612 · KZA
Ironmaster, Inc.
General Hospital · 140d
Cleared Dec 14, 1998
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · FYA
Medline Industries, Inc.
General Hospital · 133d
Cleared Dec 14, 1998
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN...
K983489 · KGO
Ansell Perry
General Hospital · 70d
Cleared Dec 11, 1998
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Dec 11, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
K983730 · LZA
Omnigrace , Ltd.
General Hospital · 50d
Cleared Dec 10, 1998
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
K983412 · LJS
Medical Components, Inc.
General Hospital · 73d
Cleared Dec 09, 1998
MELODIE INFUSION PUMP
K980378 · FRN
Compagnie DE Developpement Aguettant
General Hospital · 313d
Cleared Dec 08, 1998
CLINICAL ELECTRONIC THERMOMETER
K982140 · FLL
Valeo Corp.
General Hospital · 174d
Cleared Dec 07, 1998
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054 · JOJ
Albert Browne , Ltd.
General Hospital · 259d
Cleared Dec 07, 1998
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K981917 · LYY
Oon Corp. Resources
General Hospital · 189d
Cleared Dec 07, 1998
ARSOFT
K983146 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 90d
Cleared Dec 07, 1998
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
K983721 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K983725 · LZA
Omnigrace , Ltd.
General Hospital · 46d
Cleared Dec 04, 1998
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K981816 · FRN
Becton Dickinson Curlin, LLC
General Hospital · 196d
Cleared Dec 04, 1998
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
K982885 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 109d
Cleared Dec 04, 1998
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K983645 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 49d
Cleared Dec 04, 1998
NITRILE LATEX POWDERED EXAMINATION GLOVE
K983816 · LZA
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Dec 04, 1998
NITRILE LATEX POWDER FREE EXAMINATION GLOVE
K983825 · LZA
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Dec 04, 1998
AMERSE 2
K983947 · LRJ
STERIS Corporation
General Hospital · 29d