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
5713–5736 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 25, 2007
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · FRN
Baxter Healthcare Corp
General Hospital · 458d
Cleared Jan 23, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVE
K070035 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 20d
Cleared Jan 23, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
K063524 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 62d
Cleared Jan 19, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K070006 · LYZ
Zibo Hengde Plastic & Rubber Products...
General Hospital · 16d
Cleared Jan 12, 2007
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS...
K063747 · MSH
Inovel, LLC
General Hospital · 24d
Cleared Jan 12, 2007
RELIANCE CI PROCESS INDICATOR
K063285 · JOJ
Albert Browne , Ltd.
General Hospital · 73d
Cleared Jan 12, 2007
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
K061430 · FEB
Custom Ultrasonics
General Hospital · 234d
Cleared Jan 09, 2007
HUMAPEN LUXURA HD
K063151 · NSC
Eli Lilly and Co.
General Hospital · 85d
Cleared Jan 05, 2007
STEAMPLUS STEAM INTEGRATOR
K063799 · JOJ
Spsmedical Supply Corp.
General Hospital · 14d
Cleared Jan 05, 2007
CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
K062780 · MEG
Medical Device Manufacturer...
General Hospital · 109d
Cleared Jan 03, 2007
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
K062318 · MEG
Biotop Technology Co., Ltd.
General Hospital · 147d
Cleared Dec 26, 2006
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · FMF
Terumo Medical Corp.
General Hospital · 21d
Cleared Dec 22, 2006
ALLERGEAZE PATCH TEST CHAMBERS
K063160 · KXF
Smartpractice
General Hospital · 66d
Cleared Dec 22, 2006
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN...
K062965 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 84d
Cleared Dec 22, 2006
BONE INJECTION GUN (B.I.G.)
K062940 · FMI
Waismed, Ltd.
General Hospital · 85d
Cleared Dec 22, 2006
INTERDRY TEXTILE WITH SILVER
K061615 · FRL
Milliken Chemical
General Hospital · 196d
Cleared Dec 22, 2006
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV...
K060851 · LGZ
The Smithworks Company
General Hospital · 269d
Cleared Dec 21, 2006
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · KGO
Hartalega Sdn Bhd
General Hospital · 83d
Cleared Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 77d
Cleared Dec 15, 2006
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW
K062714 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 95d
Cleared Dec 14, 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · FYA
Medline Industries, Inc.
General Hospital · 76d
Cleared Dec 12, 2006
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
K061033 · KCT
Miltex, Inc.
General Hospital · 242d
Cleared Dec 11, 2006
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528,...
K063239 · FPK
Hospira, Inc.
General Hospital · 46d
Cleared Dec 11, 2006
ISECURE SYRINGE CARTRIDGE HOLDER
K063180 · IQG
Hospira, Inc.
General Hospital · 53d