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
4057–4080 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
K113470 · FPA
Nipro Medical Corporation
General Hospital · 330d
Cleared Oct 16, 2012
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
K122465 · LZA
Industrial Clothings, Ltd.
General Hospital · 64d
Cleared Oct 16, 2012
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K121992 · LZA
Xinwei (Shandong) Plastic and Rubber...
General Hospital · 102d
Cleared Oct 16, 2012
DISPOSABLE SURGICAL GOWNS
K120192 · FYA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 267d
Cleared Oct 15, 2012
AUTOJECT 2 FOR GLASSY SYRINGE
K122837 · KZH
Owen Mumford, Ltd.
General Hospital · 28d
Cleared Oct 15, 2012
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS
K112087 · KCT
Advanced Sterilization Products
General Hospital · 452d
Cleared Oct 12, 2012
RAPICIDE OPA-28 TEST STRIP
K120652 · JOJ
Serim Research Corp.
General Hospital · 224d
Cleared Oct 11, 2012
WIRELESS THERMOMETER
K121696 · FLL
Raling Medical Company
General Hospital · 126d
Cleared Oct 11, 2012
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND...
K121591 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 133d
Cleared Oct 04, 2012
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
K122044 · FRC
Advanced Sterilization Products
General Hospital · 84d
Cleared Oct 04, 2012
MIXJECT WITH SPRAY HEAD
K122023 · FMF
Medimop Medical Projects, Ltd.
General Hospital · 85d
Cleared Oct 04, 2012
ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
K120110 · LZA
Profit Point Manufacturing Sdn Bhd
General Hospital · 265d
Cleared Oct 03, 2012
HT-WEDGE
K121287 · FNG
D.T. Davis Enterprises Ltd. T/A...
General Hospital · 156d
Cleared Oct 03, 2012
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519 · JOJ
Advanced Sterilization Products
General Hospital · 489d
Cleared Oct 03, 2012
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · JOJ
Advanced Sterilization Products
General Hospital · 489d
Cleared Oct 02, 2012
GIRAFFE AND PANDA WARMERS
K122267 · FMT
Ohmeda Medical, A Division of...
General Hospital · 64d
Cleared Sep 28, 2012
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
K122263 · ODY
Symmetry Medical
General Hospital · 63d
Cleared Sep 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122266 · LYZ
Shandong Junfeng Industries Co., Ltd.
General Hospital · 59d
Cleared Sep 27, 2012
RAPICIDE OPA-28
K120306 · MED
Minntech Corp.
General Hospital · 239d
Cleared Sep 26, 2012
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500...
K122507 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Cleared Sep 26, 2012
STERRAD (R) 100NX DUO CYCLE TEST PACK
K111391 · FRC
Advanced Sterilization Products
General Hospital · 497d
Cleared Sep 21, 2012
HUMID-VENT HEPA
K112958 · CAH
Teleflex Medical
General Hospital · 352d
Cleared Sep 20, 2012
ULTRASAFE PASSIVE NEEDLE GUARD
K122558 · MEG
Safety Syringes, Inc.
General Hospital · 29d
Cleared Sep 20, 2012
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K122545 · LJS
Arrow International (Subsidiary of...
General Hospital · 30d