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
5185–5208 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 30, 2009
ALL-IN-ONE CONTAINER
K090096 · KPE
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Jan 30, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
K083717 · LZA
Gx Corporation Sdn Bhd
General Hospital · 46d
Cleared Jan 30, 2009
PATIENT ISOLATION UNIT, MODEL G019-1000
K080117 · LGM
Gentex Corporation
General Hospital · 379d
Cleared Jan 27, 2009
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
K083337 · LYY
Terang Nusa Sdn Bhd
General Hospital · 76d
Cleared Jan 23, 2009
PASTURE, MODELS: F550, A520
K083176 · NZJ
Pasture Pharma Pte, Ltd.
General Hospital · 87d
Cleared Jan 23, 2009
AIRGENT, MODEL AG7000010
K082138 · KZE
Perfaction, Inc.
General Hospital · 178d
Cleared Jan 23, 2009
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · CAH
Medisize BV
General Hospital · 235d
Cleared Jan 16, 2009
MEDIGARD BLOOD COLLECTION DEVICE
K082511 · FMI
Medigard Limited
General Hospital · 140d
Cleared Jan 15, 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 196d
Cleared Jan 13, 2009
INTRATEMP SOLUTION WARMER
K083417 · LHC
C Change Surgical, LLC
General Hospital · 56d
Cleared Jan 12, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082936 · LYZ
Zibo Litong Plastic Products Co., Ltd.
General Hospital · 103d
Cleared Jan 07, 2009
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
K082598 · LZA
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 121d
Cleared Jan 07, 2009
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
K073618 · FRC
STERIS Corporation
General Hospital · 378d
Cleared Dec 30, 2008
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
K083765 · FPA
Medegen Medical Manufacturing Services
General Hospital · 12d
Cleared Dec 30, 2008
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · FLE
STERIS Corporation
General Hospital · 130d
Cleared Dec 23, 2008
MISER CONTRAST MANAGEMENT SYSTEM
K083576 · FPA
Merit Medical Systems, Inc.
General Hospital · 20d
Cleared Dec 23, 2008
SUBCUTANEOUS NEEDLE INFUSION SET
K082818 · FPA
Marcal Medical, Inc.
General Hospital · 89d
Cleared Dec 23, 2008
BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
K081971 · LZC
Nitritex (M) Sdn. Bhd.
General Hospital · 166d
Cleared Dec 18, 2008
STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
K082837 · NGT
Excelsior Medical Corp.
General Hospital · 83d
Cleared Dec 18, 2008
ASTOFLO PLUS
K082765 · LGZ
Stihler Electronic GmbH
General Hospital · 87d
Cleared Dec 17, 2008
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
K082783 · MRZ
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 17, 2008
SYMPHONY METER REMOTE
K082590 · LZG
Lifescan, Inc.
General Hospital · 100d
Cleared Dec 17, 2008
FLOWPICC CATHETER
K082481 · LJS
Vasonova, Inc.
General Hospital · 111d
Cleared Dec 17, 2008
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
K081788 · FLL
Innochips Technology Co., Ltd.
General Hospital · 176d