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
4921–4944 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 17, 2009
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
K093546 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 30d
Cleared Dec 17, 2009
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER
K093252 · LJS
Footprint Medical, Inc.
General Hospital · 62d
Cleared Dec 17, 2009
DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES
K092557 · FLL
Harvard Medical Devices , Ltd.
General Hospital · 119d
Cleared Dec 17, 2009
LAC-MAC INNERBLOC LR SURGICAL GOWNS
K092344 · FYA
Lac Mac, Ltd.
General Hospital · 135d
Cleared Dec 16, 2009
LOUSEBUSTER
K093144 · LJL
Larada Sciences
General Hospital · 72d
Cleared Dec 11, 2009
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
K092682 · KCT
Gyrus Acmi, Inc.
General Hospital · 101d
Cleared Dec 09, 2009
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL...
K093332 · FRN
Delphi Medical Systems
General Hospital · 44d
Cleared Dec 08, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092966 · LYZ
Jin Zhou Chang Hao Plastic Products...
General Hospital · 74d
Cleared Dec 07, 2009
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK,...
K092782 · LHI
Carmel Pharma Ab.
General Hospital · 88d
Cleared Dec 04, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K093570 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 16d
Cleared Dec 04, 2009
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK
K093199 · JOJ
3M Company
General Hospital · 56d
Cleared Dec 04, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092956 · LYZ
Shandong Aobo Medical Co, Ltd.
General Hospital · 70d
Cleared Dec 03, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092820 · LYZ
Shijiazhuang Fuhao Plastic Products...
General Hospital · 80d
Cleared Dec 02, 2009
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN...
K093375 · LYY
Koon Seng Sdn Bhd
General Hospital · 34d
Cleared Dec 02, 2009
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
K092958 · FLL
Avita Corporation
General Hospital · 68d
Cleared Dec 02, 2009
TSO3 OZONE STERILIZER, MODEL 125L
K090636 · FLF
Tso3, Inc.
General Hospital · 267d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093277 · LYZ
Tangshan Green Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093272 · LYZ
Tangshan Huamei Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 27, 2009
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152
K092959 · FLL
Avita Corporation
General Hospital · 63d
Cleared Nov 27, 2009
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092160 · LZA
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 134d
Cleared Nov 24, 2009
NMI PICC II
K093366 · LJS
Navilyst Medical, Inc.
General Hospital · 26d
Cleared Nov 24, 2009
PRO-LINE CT (BASIC TRAY) MODEL MR28036101
K093309 · LJS
Medcomp ( Medical Components)
General Hospital · 33d
Cleared Nov 24, 2009
POWDER FREE NITRILE EXAMINATION GLOVES BLACK
K091965 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 146d
Cleared Nov 20, 2009
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE...
K092499 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 98d