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
4969–4992 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 21, 2009
POWDER FREE EXAMINATION GLOVE
K092296 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 84d
Cleared Oct 21, 2009
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
K092294 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 84d
Cleared Oct 21, 2009
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
K082756 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 397d
Cleared Oct 19, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
K092034 · LZA
Pt. Smartglove Indonesia
General Hospital · 105d
Cleared Oct 15, 2009
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
K091471 · LYZ
Cartagloves S.A.
General Hospital · 150d
Cleared Oct 14, 2009
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION...
K091140 · FMI
Vidacare Corporation
General Hospital · 177d
Cleared Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709 · FOZ
Edwards Lifesciences, LLC
General Hospital · 125d
Cleared Oct 13, 2009
DISPOSABLE TPE INFUSION SET
K090459 · FPA
Shan Dong Wei Gao Group Medical...
General Hospital · 232d
Cleared Oct 09, 2009
BUSSE SURGICAL DRAPES III
K092212 · KKX
Busse Hospital Disposables, Inc.
General Hospital · 79d
Cleared Oct 09, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092109 · LYZ
Zhangjiangang All Fine Rubber-Plastic...
General Hospital · 87d
Cleared Oct 09, 2009
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K090650 · JOJ
Spsmedical Supply Corp.
General Hospital · 212d
Cleared Oct 08, 2009
REMOTE INFRARED THERMOMETER, MODEL RC002
K090361 · FLL
Rycom Electron Technology Limited
General Hospital · 238d
Cleared Oct 07, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092516 · LYZ
Zi BO Yuxiang Gloves Co., Ltd.
General Hospital · 51d
Cleared Oct 06, 2009
FLEXICARE BREATHING FILTERS
K092218 · CAH
Flexicare Medical, Ltd.
General Hospital · 76d
Cleared Oct 02, 2009
SUPER-FINE PEN NEEDLE
K092016 · FMI
Stat Medical Devices, Inc.
General Hospital · 88d
Cleared Oct 02, 2009
MICROFUSE DUAL RATE INFUSER
K091386 · FRN
Numia Medical Technology, LLC
General Hospital · 144d
Cleared Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568 · LZA
Medline Industries, Inc.
General Hospital · 213d
Cleared Sep 29, 2009
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER...
K090117 · FMI
Autosafe-Reflex, Inc.
General Hospital · 251d
Cleared Sep 25, 2009
SNM FIRMGRIP
K092629 · FOZ
Flexicath , Ltd.
General Hospital · 29d
Cleared Sep 25, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092415 · LYZ
Shijiazhuang Elegance Plastic Product
General Hospital · 50d
Cleared Sep 25, 2009
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE)...
K092012 · FXX
Primed Medical Products, Inc.
General Hospital · 81d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
K091214 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
K091213 · FOS
Footprint Medical
General Hospital · 151d
Cleared Sep 25, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082648 · LYZ
Tangshan Dar Plastic & Rubber...
General Hospital · 379d