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
7417–7440 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 13, 2001
AUTOJECT 2
K013362 · KZH
Owen Mumford USA, Inc.
General Hospital · 34d
Cleared Nov 13, 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL...
K013603 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
K013604 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 08, 2001
3CC NMT SAFETY SYRINGE
K010819 · MEG
New Medical Technology , Ltd.
General Hospital · 234d
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013073 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 55d
Cleared Nov 08, 2001
LIFTLOC SAFETY INFUSION SET
K013394 · FPA
Specialized Health Products, Inc.
General Hospital · 24d
Cleared Nov 06, 2001
SURESET INFUSION SET, MODEL 8023
K012429 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 98d
Cleared Nov 05, 2001
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
K002937 · LRT
Albert Browne , Ltd.
General Hospital · 410d
Cleared Oct 31, 2001
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH...
K012714 · LYY
Koon Seng Sdn Bhd
General Hospital · 78d
Cleared Oct 29, 2001
CW DISPOSABLE ACUPUNCTURE NEEDLE
K011248 · MQX
Acusupply, Inc.
General Hospital · 189d
Cleared Oct 29, 2001
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · FMF
Micromedics, Inc.
General Hospital · 63d
Cleared Oct 25, 2001
MONOJECT SAFETY NEEDLE
K012736 · FMI
Tyco Healthcare
General Hospital · 70d
Cleared Oct 24, 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · MEG
Safegard Medical Products, Inc.
General Hospital · 110d
Cleared Oct 24, 2001
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · LGZ
Nxstage Medical, Inc.
General Hospital · 62d
Cleared Oct 19, 2001
RIWO SYSTEM TRAYS
K012309 · FEB
Richard Wolf Medical Instruments Corp.
General Hospital · 88d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · LZA
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 18, 2001
PROSAFE SAFETY SYRINGE
K012726 · MEG
Hou-Se Medical, Inc.
General Hospital · 64d
Cleared Oct 17, 2001
HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011247 · MQX
Acusupply, Inc.
General Hospital · 177d
Cleared Oct 16, 2001
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K012339 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 84d
Cleared Oct 16, 2001
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K012499 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 74d
Cleared Oct 15, 2001
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K011283 · NGT
The Kendall Company
General Hospital · 171d
Cleared Oct 15, 2001
MERTEX-PLUS REUSABLE SURGICAL DRAPE
K012237 · KKX
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
K012240 · FYA
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
FAS ENDOLUMINAL BRUSH
K012641 · LJS
Fas Medical , Ltd.
General Hospital · 63d