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
5953–5976 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 17, 2006
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
K053345 · LJS
Medcomp
General Hospital · 105d
Cleared Mar 16, 2006
EQUIPMENT SLUSH DRAPE
K053495 · KKX
Advance Medical Designs, Inc.
General Hospital · 91d
Cleared Mar 15, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50...
K060229 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 44d
Cleared Mar 13, 2006
ONE TRAY SEALED STERILIZATION CONTAINER
K052567 · KCT
Sterile Containment Technology, LLC
General Hospital · 175d
Cleared Mar 10, 2006
CAREO SAFETY SYRINGE 1CC/ML, MODELS...
K060208 · MEG
Life-Shield Products, Inc.
General Hospital · 42d
Cleared Mar 10, 2006
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
K053102 · KGO
Regent Medical Americas, LLC
General Hospital · 126d
Cleared Mar 08, 2006
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
K060337 · FLE
Sauter AG
General Hospital · 26d
Cleared Mar 07, 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · FYA
Standard Textile Co., Inc.
General Hospital · 43d
Cleared Mar 07, 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
K060103 · JOJ
Albert Browne , Ltd.
General Hospital · 53d
Cleared Mar 07, 2006
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
K053442 · KGO
Regent Medical Americas, LLC
General Hospital · 88d
Cleared Mar 02, 2006
VYGON LATEX FREE BIONECTOR
K052881 · FOZ
Vygon Corp.
General Hospital · 141d
Cleared Feb 27, 2006
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
K052665 · FRG
Granton Medical , Ltd.
General Hospital · 153d
Cleared Feb 24, 2006
ABRACAIR AIR CLEANER, MODEL QTZ300-60
K052732 · FRA
Abracair, Inc.
General Hospital · 148d
Cleared Feb 22, 2006
ISSYS DRUG FLOW MONITOR
K050783 · FLN
Integrated Sensing Systems, Inc.
General Hospital · 331d
Cleared Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174 · FOZ
Cook, Inc.
General Hospital · 25d
Cleared Feb 15, 2006
AESCULAP STERILCONTAINER SYSTEM
K053389 · FRG
Aesculap, Inc.
General Hospital · 72d
Cleared Feb 15, 2006
RAVEN PROPACT
K053212 · MRB
Raven Biological Laboratories, Inc.
General Hospital · 91d
Cleared Feb 15, 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · KKX
Medline Industries, Inc.
General Hospital · 132d
Cleared Feb 14, 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · FLN
Smith & Nephew, Inc.
General Hospital · 27d
Cleared Feb 14, 2006
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
K053523 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 57d
Cleared Feb 13, 2006
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K053657 · LZA
Pt Mahakarya Inti Buana
General Hospital · 70d
Cleared Feb 13, 2006
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
K052797 · FYD
Medtek Devices, Inc.
General Hospital · 133d
Cleared Feb 10, 2006
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
K060211 · FMF
Wenzhou Wuzhou Group Co. , Ltd.
General Hospital · 14d
Cleared Feb 10, 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · FMF
Wrightmedicaltechnologyinc
General Hospital · 28d