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
4513–4536 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 15, 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR...
K103524 · FPL
International Biomedical, Ltd.
General Hospital · 135d
Cleared Apr 14, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102085 · LYZ
Shijiazhuang Glory Plastic Co., Ltd.
General Hospital · 262d
Cleared Apr 14, 2011
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M...
K101468 · FYA
3M Company Corp
General Hospital · 322d
Cleared Apr 13, 2011
EVA TPN BAG
K101412 · KPE
Valmed S.R.L.
General Hospital · 328d
Cleared Apr 12, 2011
INFUSION ADAPTER C100
K110023 · LHI
Carmel Pharma Ab.
General Hospital · 99d
Cleared Apr 12, 2011
PROPEP DELIVERY DEVICE
K103200 · FMF
Rhythmlink International, LLC
General Hospital · 162d
Cleared Apr 06, 2011
MICROLIFE DIGITAL UNDERARM THERMOMETER
K103680 · FLL
Microlife Intellectual Property GmbH
General Hospital · 110d
Cleared Apr 06, 2011
DISPOSABLE BLLOD COLLECTION NEEDLE
K103587 · FMI
Weihai Hongyu Medical Devices Co., Ltd.
General Hospital · 120d
Cleared Apr 05, 2011
SHARPS CONTAINER
K110262 · MMK
Noble Marketing
General Hospital · 67d
Cleared Apr 04, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110185 · LZA
Tangshan Baojie Glove Co., Ltd.
General Hospital · 73d
Cleared Apr 04, 2011
DIGITAL FOREHEAD THERMOMETER
K103617 · FLL
K-Jump Health Co., Ltd.
General Hospital · 115d
Cleared Apr 01, 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · JOJ
Advanced Sterilization Products
General Hospital · 151d
Cleared Apr 01, 2011
STERRAD CHEMICAL INDICATOR STRIP
K103218 · JOJ
Advanced Sterilization Products
General Hospital · 151d
Cleared Mar 31, 2011
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
K103670 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 105d
Cleared Mar 29, 2011
BILI-THERAPY SPOT TYPE
K103828 · LBI
Atom Medical Corporation
General Hospital · 91d
Cleared Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE...
K103551 · FPA
Baxter Healthcare Corp
General Hospital · 113d
Cleared Mar 25, 2011
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · MEG
Medline Industries, Inc.
General Hospital · 294d
Cleared Mar 23, 2011
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
K103661 · LZA
Rubbercare Protection Products Sdn Bhd
General Hospital · 97d
Cleared Mar 23, 2011
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM...
K103650 · LYY
Oon Corp. Resources
General Hospital · 99d
Cleared Mar 18, 2011
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE
K110224 · LYZ
Weifang Beihai Color Printing...
General Hospital · 52d
Cleared Mar 17, 2011
PATIENT EXAMINATION GLOVES
K102846 · LZA
Thai Hua Holding Co., Ltd.
General Hospital · 169d
Cleared Mar 16, 2011
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K110453 · NZA
STERIS Corporation
General Hospital · 28d
Cleared Mar 16, 2011
GETINGE 400HC/500HC SERIES STEAM STERILIZER
K103504 · FLE
Getinge Sourcing, LLC
General Hospital · 110d
Cleared Mar 15, 2011
BELIMED STEAM STERILIZER MST-V
K103841 · FLE
Sauter AG
General Hospital · 83d