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
4897–4920 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 04, 2010
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202,...
K091363 · CAH
Ag Industries
General Hospital · 272d
Cleared Feb 03, 2010
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT...
K093496 · LYY
Oon Corp. Resources
General Hospital · 85d
Cleared Feb 03, 2010
MICRONJET 600
K092746 · FMI
Nanopass Technologies , Ltd.
General Hospital · 148d
Cleared Feb 03, 2010
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML
K092491 · NZW
Medefil, Inc.
General Hospital · 174d
Cleared Feb 01, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR
K093727 · LYZ
Zibo Bolin Gloves Co., Ltd.
General Hospital · 60d
Cleared Feb 01, 2010
FLEXPEN NEEDLE
K090111 · FMI
Novo Nordisk, Inc.
General Hospital · 381d
Cleared Jan 28, 2010
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
K091583 · NGT
Medefil, Inc.
General Hospital · 240d
Cleared Jan 27, 2010
EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV...
K093271 · FPA
Victus, Inc.
General Hospital · 100d
Cleared Jan 27, 2010
SET GRI-FILL 3.0
K093182 · LHI
Laboratorios Grifols, S.A.
General Hospital · 111d
Cleared Jan 25, 2010
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
K093364 · LZG
Medingo , Ltd.
General Hospital · 89d
Cleared Jan 20, 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · OPP
Calibra Medical, Inc.
General Hospital · 112d
Cleared Jan 19, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE...
K093500 · LZC
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 68d
Cleared Jan 15, 2010
SMART-WELL EZTEST INCUBATOR
K091950 · FRC
Sgm Biotech, Inc.
General Hospital · 198d
Cleared Jan 14, 2010
DISPOSABLE HYPODERMIC NEEDLE
K092831 · FMI
Feel Tech
General Hospital · 121d
Cleared Jan 07, 2010
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
K092447 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 150d
Cleared Jan 07, 2010
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
K092346 · JOJ
Serim Research Corp.
General Hospital · 156d
Cleared Jan 04, 2010
EXEL I.V. EXTENSION SET
K092172 · FPA
Exelint Intl. Co.
General Hospital · 167d
Cleared Dec 30, 2009
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · FRC
STERIS Corporation
General Hospital · 100d
Cleared Dec 28, 2009
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH...
K091851 · LZA
Gx Corporation Sdn Bhd
General Hospital · 189d
Cleared Dec 24, 2009
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
K090959 · KZE
D'Antonio Consultants International,...
General Hospital · 262d
Cleared Dec 22, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093439 · LYZ
Tangshan Pufa Plastic Products Co., Ltd.
General Hospital · 48d
Cleared Dec 18, 2009
AMSCO WARMING CABINET
K092823 · LGZ
STERIS Corporation
General Hospital · 95d
Cleared Dec 18, 2009
DYNAREX STERILE LUBRICATING JELLY
K092488 · KMJ
Dynarex Corporation
General Hospital · 127d
Cleared Dec 18, 2009
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02,...
K090921 · DWL
Beiersdorf, Inc.
General Hospital · 261d