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
4417–4440 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 29, 2011
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
K103830 · FMF
Jiangsu Shenli Medical Production...
General Hospital · 211d
Cleared Jul 29, 2011
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
K103740 · NGT
Spectra Medical Devices, Inc.
General Hospital · 219d
Cleared Jul 27, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K111752 · LYZ
Shandong Jianhong New Material Company
General Hospital · 35d
Cleared Jul 27, 2011
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS...
K111517 · KZE
Pharmajet, Inc.
General Hospital · 55d
Cleared Jul 27, 2011
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · FMI
Becton, Dickinson and Company
General Hospital · 135d
Cleared Jul 21, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110970 · LYZ
Ppp Medical and Safety Products...
General Hospital · 106d
Cleared Jul 21, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
K110966 · LYZ
Ppp Medical and Safety Products...
General Hospital · 106d
Cleared Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
K102405 · FPA
C.R. Bard, Inc.
General Hospital · 331d
Cleared Jul 20, 2011
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
K111598 · LYZ
Lpl (Hui Zhou) Glove Co., Ltd.
General Hospital · 42d
Cleared Jul 20, 2011
STERI-DENT, STERI-SURE
K110867 · FRG
Cpac, Inc.
General Hospital · 113d
Cleared Jul 19, 2011
BD INSYTE AUTOGUARD BC
K110443 · FOZ
Becton, Dickinson & CO
General Hospital · 153d
Cleared Jul 18, 2011
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
K110956 · FLL
Medivance, Inc.
General Hospital · 104d
Cleared Jul 15, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K111328 · LZA
Gx Corporation Sdn Bhd
General Hospital · 65d
Cleared Jul 15, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K110857 · LYZ
Shandong Zhanpeng Medical Products...
General Hospital · 109d
Cleared Jul 14, 2011
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
K111240 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 72d
Cleared Jul 14, 2011
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K111034 · NGT
Am USA
General Hospital · 92d
Cleared Jul 14, 2011
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
K110960 · LZA
Koon Seng Sdn Bhd
General Hospital · 100d
Cleared Jul 14, 2011
TIGER SYRINGES AND NEEDLES
K110697 · FMF
Tiger Medical Products, Ltd.
General Hospital · 122d
Cleared Jul 13, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K110418 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 149d
Cleared Jul 12, 2011
STERI-DENT, STERI-SURE
K094026 · KMH
Cpac, Inc.
General Hospital · 559d
Cleared Jul 11, 2011
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
K101194 · FRN
Carticept Medical, Inc.
General Hospital · 439d
Cleared Jul 08, 2011
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K111150 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 74d
Cleared Jul 07, 2011
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH...
K103714 · KGO
Ansell Healthcare Products, LLC
General Hospital · 198d
Cleared Jul 06, 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE...
K111012 · LYZ
True Glove Factory
General Hospital · 85d