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
5425–5448 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 16, 2008
NEEDLE-TRAP/NEEDLE SAFETY LABEL
K073206 · MEG
Schreiner Medipharm
General Hospital · 64d
Cleared Jan 15, 2008
PRESSURE INJECTABLE PICC
K073451 · LJS
Arrow International, Inc.
General Hospital · 36d
Cleared Jan 11, 2008
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
K072790 · FMF
Confluent Surgical,Inc
General Hospital · 102d
Cleared Jan 11, 2008
AVIATOR INSULIN PUMP
K071788 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 193d
Cleared Jan 08, 2008
N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
K072067 · MSH
Shuenn Bao Shing Corporation
General Hospital · 165d
Cleared Dec 28, 2007
ALARIS SYSTEM WITH MMS, MODEL 8XXX
K072105 · FRN
Cardinal Health 303,Inc.
General Hospital · 150d
Cleared Dec 27, 2007
SELF SEAL STERILIZATION POUCH
K071886 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 171d
Cleared Dec 20, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K073193 · LYZ
Shijiazhuang Prosperous Plastic Co.,...
General Hospital · 37d
Cleared Dec 20, 2007
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
K073127 · FMI
Shandong Weigao Group Medical Polymer...
General Hospital · 44d
Cleared Dec 20, 2007
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
K072518 · LJS
Crs Medical Diagnostics, Inc.
General Hospital · 104d
Cleared Dec 19, 2007
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423 · LJT
C.R. Bard, Inc.
General Hospital · 14d
Cleared Dec 19, 2007
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT),...
K072466 · FLE
Scican , Ltd.
General Hospital · 106d
Cleared Dec 18, 2007
STERRAD 100NX TEST PACK
K071537 · FRC
Advanced Sterilization Products
General Hospital · 196d
Cleared Dec 14, 2007
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE...
K072657 · LJT
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 14, 2007
PATIENT SAFE SYRINGE
K072654 · FMF
Retractable Technologies, Inc.
General Hospital · 85d
Cleared Dec 14, 2007
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
K072377 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 112d
Cleared Dec 14, 2007
AMIGO INSULIN PUMP
K071613 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 184d
Cleared Dec 14, 2007
SMARTSITE STOPCOCK
K071400 · FMG
Cardinal Health, Alaris Products
General Hospital · 207d
Cleared Dec 14, 2007
PLASMAIR, MODEL T2006
K070722 · FRF
Airinspace B.V.
General Hospital · 274d
Cleared Dec 13, 2007
VIAL2BAG
K072759 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 76d
Cleared Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · LJS
Cook, Inc.
General Hospital · 87d
Cleared Dec 13, 2007
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
K072511 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 98d
Cleared Dec 13, 2007
SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET
K072375 · FPA
AngioDynamics, Inc.
General Hospital · 112d
Cleared Dec 13, 2007
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE...
K071746 · KGO
Ansell Healthcare Products, LLC
General Hospital · 169d