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
4369–4392 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 21, 2011
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA...
K111868 · KGO
Cardinal Health-Medical Products and...
General Hospital · 82d
Cleared Sep 21, 2011
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
K111857 · LYZ
Inmed Gloves Factory
General Hospital · 83d
Cleared Sep 21, 2011
TRIPLE LUMEN PFM PICC
K110914 · LJS
Pfm Medical, Inc.
General Hospital · 173d
Cleared Sep 20, 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 46d
Cleared Sep 20, 2011
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · FLE
STERIS Corporation
General Hospital · 141d
Cleared Sep 16, 2011
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K112067 · FRN
Carticept Medical, Inc.
General Hospital · 59d
Cleared Sep 16, 2011
SURGICAL MASKS
K111559 · FXX
Shanghai Neo-Medical Import & Export...
General Hospital · 102d
Cleared Sep 13, 2011
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K110945 · LYZ
Zhaoyang Plastic Co., Ltd.
General Hospital · 162d
Cleared Sep 13, 2011
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K102483 · CAH
Sunset Healthcare Solutions, LLC
General Hospital · 379d
Cleared Sep 08, 2011
MEDLINE VIAL DECANTER
K111577 · LHI
Medline Industries, Inc.
General Hospital · 93d
Cleared Sep 06, 2011
MYSAFETY SYRINGE
K111734 · MEG
Medicalchain Intl. Corp.
General Hospital · 77d
Cleared Sep 02, 2011
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
K111810 · MLR
STERIS Corporation
General Hospital · 67d
Cleared Sep 02, 2011
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES,...
K111139 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 133d
Cleared Sep 01, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110944 · LYZ
Wangda Plastic Co., Ltd.
General Hospital · 150d
Cleared Sep 01, 2011
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION...
K103331 · JOJ
STERIS Corporation
General Hospital · 293d
Cleared Aug 31, 2011
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K112376 · FLL
Circa Scientific, LLC
General Hospital · 14d
Cleared Aug 30, 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4...
K111236 · FOZ
B.Braun Melsungen AG
General Hospital · 120d
Cleared Aug 29, 2011
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION...
K111386 · FRN
Smiths Medical MD, Inc.
General Hospital · 103d
Cleared Aug 26, 2011
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
K111535 · FYA
Exact Medical Manufacturing, Inc.
General Hospital · 85d
Cleared Aug 25, 2011
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
K111101 · LJT
Norfolk Medical
General Hospital · 127d
Cleared Aug 24, 2011
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 34d
Cleared Aug 24, 2011
DIGITAL THERMOMETER MT SERIES
K110776 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 156d
Cleared Aug 24, 2011
SHENGKUN CHEMICAL
K110621 · LYZ
Zibo Shengkun Chemical Industrial...
General Hospital · 174d
Cleared Aug 23, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A...
K111589 · LZA
Derma Care Plus Products, LLC
General Hospital · 77d