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
3577–3600 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 30, 2014
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL...
K130450 · KGO
Purna Bina Sdn Bhd
General Hospital · 585d
Cleared Sep 29, 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · LJS
Medical Components, Inc.
General Hospital · 103d
Cleared Sep 24, 2014
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123 · NDC
Reach Health, Inc.
General Hospital · 51d
Cleared Sep 23, 2014
STERILIZATION CASSETTE
K141616 · KCT
Oticon Medical AB
General Hospital · 99d
Cleared Sep 19, 2014
Extension Set with BD Q-Syte Luer Access Split Septum
K142527 · FPA
Acacia, Inc.
General Hospital · 11d
Cleared Sep 16, 2014
YUSHENG
K141108 · LYZ
Zibo Yusheng Plastic Products Co., Ltd.
General Hospital · 140d
Cleared Sep 15, 2014
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K141321 · NDC
Medical Decision Network
General Hospital · 118d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384 · KZH
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 12, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...
K140050 · LZA
Hartalega Sdn Bhd
General Hospital · 246d
Cleared Sep 10, 2014
GLOBE-TROTTER GT5400
K141565 · FPL
Draeger Medical Systems, Inc.
General Hospital · 90d
Cleared Sep 10, 2014
NOVAGUARD S A SAFETY SYSTEM
K141464 · MEG
West Pharmaceutical Services
General Hospital · 99d
Cleared Sep 10, 2014
SURGICAL DRAPE
K140195 · KKX
Griffith-Lucas, LLC
General Hospital · 226d
Cleared Sep 10, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130742 · LYZ
Dahoon Plastic Co., Ltd.
General Hospital · 540d
Cleared Sep 09, 2014
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL...
K141244 · FRC
North American Science Assoc., Inc.
General Hospital · 118d
Cleared Sep 09, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131340 · LYZ
Made Plastic Co., Ltd.
General Hospital · 488d
Cleared Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 71d
Cleared Sep 04, 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · FMF
Biomet Spine (Aka Ebi, LLC)
General Hospital · 167d
Cleared Sep 03, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141590 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 82d
Cleared Sep 03, 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418 · LZA
Wrp Rubber Products Sdn Bhd
General Hospital · 197d
Cleared Aug 29, 2014
SELEC-3 I.V.ADMINISTRATION SET
K142097 · FPA
Biomedix, Inc.
General Hospital · 28d
Cleared Aug 28, 2014
TOTAL SHIELD SURGICAL
K142166 · FYA
Zimmer, Inc.
General Hospital · 29d
Cleared Aug 28, 2014
NIO -INTRAOSSEOUS DEVICE
K142086 · FMI
Waismed, Ltd.
General Hospital · 28d
Cleared Aug 28, 2014
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER...
K142080 · LHC
Ecolab, Inc.
General Hospital · 28d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · FMF
Biomet, Inc.
General Hospital · 57d