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
5689–5712 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 09, 2007
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K063114 · FPK
Coeur, Inc.
General Hospital · 121d
Cleared Feb 08, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
K070043 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 36d
Cleared Feb 08, 2007
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL,...
K070028 · FLL
Actherm, Inc.
General Hospital · 36d
Cleared Feb 08, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K070008 · LYZ
Zibo Hengde Plastic & Rubber Products...
General Hospital · 36d
Cleared Feb 08, 2007
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
K063522 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 78d
Cleared Feb 08, 2007
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
K062753 · FMF
Surgimed, Inc.
General Hospital · 147d
Cleared Feb 07, 2007
POWDERED VINYL PATIENT GLOVE
K070046 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 35d
Cleared Feb 05, 2007
DERMOTHERAP GUN
K062339 · KZH
Dermoequipos S.R.L.
General Hospital · 179d
Cleared Feb 02, 2007
STRYKER T4 HYTREL TOGA
K070078 · FYA
Stryker Instruments, Instruments Div.
General Hospital · 24d
Cleared Feb 02, 2007
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A,...
K063711 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 50d
Cleared Feb 02, 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · FLL
ACON Laboratories, Inc.
General Hospital · 81d
Cleared Feb 02, 2007
DANA DIABECARE IIS
K063126 · LZG
Sooil Development Co., Ltd.
General Hospital · 112d
Cleared Feb 02, 2007
STRYKER AUTO IRRIGATION SYSTEM
K061108 · FRN
Stryker
General Hospital · 288d
Cleared Feb 01, 2007
VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
K062414 · LJT
Rita Medical Systems, Inc.
General Hospital · 168d
Cleared Jan 29, 2007
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION
K070044 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 26d
Cleared Jan 26, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE
K070040 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 23d
Cleared Jan 26, 2007
AUTO-FILL SYRINGE KIT, MODEL 7600
K063851 · FMF
Vascular Solutions, Inc.
General Hospital · 29d
Cleared Jan 26, 2007
EZ-MIO STERNAL
K063567 · FMI
Vidacare Corporation
General Hospital · 59d
Cleared Jan 26, 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE,...
K063530 · MEB
I-Flow Corp.
General Hospital · 65d
Cleared Jan 25, 2007
SHARPS CONTAINER, MODEL 039-413
K063666 · MMK
Biodex Medical Systems, Inc.
General Hospital · 45d
Cleared Jan 25, 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1,...
K063450 · FMI
Smiths Medical Asd, Inc.
General Hospital · 71d
Cleared Jan 25, 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377 · LJT
C.R. Bard, Inc.
General Hospital · 78d
Cleared Jan 25, 2007
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · FYA
Microtek Medical, Inc.
General Hospital · 120d
Cleared Jan 25, 2007
DERMATHERAPY, MODEL 22216
K061242 · FMW
Precision Fabrics Group, Inc.
General Hospital · 267d