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
6217–6240 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 27, 2005
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
K050508 · KKX
Haywood Vocational Opportunities
General Hospital · 58d
Cleared Apr 27, 2005
INFPUMP INFILTRATION PUMP
K050324 · FRN
Carolina Medical, Inc.
General Hospital · 77d
Cleared Apr 26, 2005
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
K050533 · KGO
Regent Medical Americas, LLC
General Hospital · 55d
Cleared Apr 25, 2005
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B,...
K042526 · KKX
Medical Action Industries, Inc.
General Hospital · 220d
Cleared Apr 22, 2005
STAT MEDICAL PEN NEEDLE
K042917 · FMI
Emergogroup, Inc.
General Hospital · 182d
Cleared Apr 22, 2005
STERRAD NX STERILIZER
K042116 · MLR
Advanced Sterilization Products
General Hospital · 260d
Cleared Apr 18, 2005
BARDPORT TITANIUM PORTS
K050310 · LJT
Bard Access Systems, Inc.
General Hospital · 69d
Cleared Apr 18, 2005
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN...
K050122 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 89d
Cleared Apr 15, 2005
P&P SAFETY SYRINGE
K043419 · MEG
Medexel Medical Mfg. Co., Ltd.
General Hospital · 123d
Cleared Apr 15, 2005
MICROFLO-SAFE SCALP VEIN SET
K043328 · FPA
Dks Loversan Industria Biomedica Spa
General Hospital · 134d
Cleared Apr 15, 2005
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
K041495 · FPA
Pentaferte S.P.A
General Hospital · 315d
Cleared Apr 14, 2005
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
K050770 · MEB
Mckinley Medical, LLC
General Hospital · 20d
Cleared Apr 14, 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K050532 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 14, 2005
VEINNOVATIONS INFILTRATION SYSTEM
K050474 · FRN
Veinnovations, LLC
General Hospital · 49d
Cleared Apr 13, 2005
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
K050433 · FRN
Zimmer Orthopaedic Surgical Products
General Hospital · 50d
Cleared Apr 13, 2005
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K050181 · KGO
Medigloves , Ltd.
General Hospital · 76d
Cleared Apr 11, 2005
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
K050193 · MSH
Louis M. Gerson Co., Inc.
General Hospital · 74d
Cleared Apr 08, 2005
LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE
K050765 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 15d
Cleared Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529 · NDC
Roche Diagnostics Corp.
General Hospital · 108d
Cleared Apr 07, 2005
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
K050664 · FRC
Getinge USA, Inc.
General Hospital · 23d
Cleared Apr 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY...
K050598 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 29d
Cleared Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
K050207 · FPA
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Apr 05, 2005
DEPOTONE
K050505 · FMI
Imprint Pharmaceuticals Limited
General Hospital · 36d
Cleared Apr 05, 2005
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · MEG
Formosa Medical Devices, Inc.
General Hospital · 74d