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
5593–5616 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 29, 2007
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · FMF
Terumo Europe N.V.
General Hospital · 120d
Cleared May 25, 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · MEB
Baxter Healthcare Corp
General Hospital · 23d
Cleared May 25, 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547 · FPA
Terumo Europe N.V.
General Hospital · 88d
Cleared May 24, 2007
TEXIUM SYRINGE
K071108 · FMF
Cardinal Health, Alaris Products
General Hospital · 35d
Cleared May 24, 2007
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · FRC
Advanced Sterilization Products
General Hospital · 44d
Cleared May 24, 2007
IMM HYPODERMIC NEEDLE SET
K070801 · FPA
Innovative Medical Manufacturing Co.
General Hospital · 62d
Cleared May 24, 2007
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
K070595 · FRC
Spsmedical Supply Corp.
General Hospital · 83d
Cleared May 24, 2007
WELMED, INC. SURGICAL GOWNS
K070431 · FYA
Welmed, Inc.
General Hospital · 100d
Cleared May 23, 2007
POWER PORT-A-CATH AND POWER PORT-A-CATH II
K070116 · LJT
Smiths Medical MD, Inc.
General Hospital · 131d
Cleared May 18, 2007
BODYGUARD PAIN MANAGER INFUSION SYSTEM
K070235 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 113d
Cleared May 18, 2007
WALLABY 4
K070180 · LBI
Respironics Inc., Sleep & Home...
General Hospital · 119d
Cleared May 15, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K070861 · LZA
Hong Xin Rubber Products Co., Ltd.
General Hospital · 48d
Cleared May 15, 2007
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE...
K070003 · LJT
Medcomp
General Hospital · 132d
Cleared May 10, 2007
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200...
K070821 · LYY
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 45d
Cleared May 08, 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared May 08, 2007
AFF (MARK I) VOLUMETRIC INFUSION PUMP
K070529 · FRN
Definitive Medical Technologies, Ltd.
General Hospital · 74d
Not Cleared May 08, 2007
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE
DEN060009 · NZJ
3M Company
General Hospital · 217d
Cleared May 07, 2007
SURFLO WINGED INFUSION SET
K070362 · FPA
Terumo Europe N.V.
General Hospital · 89d
Cleared May 07, 2007
FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
K063363 · LJS
Flexicath , Ltd.
General Hospital · 181d
Cleared May 04, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070615 · LJS
AngioDynamics, Inc.
General Hospital · 60d
Cleared May 04, 2007
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
K062784 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 228d
Cleared Apr 27, 2007
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
K071019 · FLL
Mesure Technology Co., Ltd.
General Hospital · 17d
Cleared Apr 26, 2007
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · KGO
Zimmer, Inc.
General Hospital · 146d
Cleared Apr 24, 2007
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
K070398 · FRN
Hospira, Inc.
General Hospital · 71d