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
5257–5280 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 30, 2008
SECURACATH CATHETER, MODEL SPK01
K082047 · OKC
Interrad Medical, Inc.
General Hospital · 74d
Cleared Sep 30, 2008
POWDER-FREE VINYL EXAMINATION GLOVES
K081658 · LYZ
Jiangsu Alfa Glove Co., Ltd.
General Hospital · 110d
Cleared Sep 30, 2008
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
K081425 · LJT
Cook Vascular, Inc.
General Hospital · 132d
Cleared Sep 29, 2008
QUICKPIN
K082752 · LHI
Laboratorios Grifols, S.A.
General Hospital · 10d
Cleared Sep 26, 2008
HASELMEIER PEN 8
K082616 · FMF
Haselmeier GmbH
General Hospital · 17d
Cleared Sep 26, 2008
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K082443 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 32d
Cleared Sep 26, 2008
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
K082029 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 71d
Cleared Sep 26, 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K081539 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 116d
Cleared Sep 25, 2008
SERIM DISINTEK OPA TEST STRIP
K082352 · JOJ
Serim Research Corp.
General Hospital · 40d
Cleared Sep 23, 2008
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904 · LJS
Medcomp
General Hospital · 82d
Cleared Sep 23, 2008
SMARTPORT CT VORTEX
K081472 · LJT
AngioDynamics, Inc.
General Hospital · 119d
Cleared Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
K082362 · FOZ
Terumo Medical Corp.
General Hospital · 30d
Cleared Sep 17, 2008
INFRARED EAR THERMOMETER, MODEL ET-101A
K082192 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 44d
Cleared Sep 17, 2008
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Sep 12, 2008
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR...
K081569 · LZA
Dynarex Corporation
General Hospital · 100d
Cleared Sep 11, 2008
EFFECTIV (TM) CAP
K080579 · QBP
Hospira, Inc.
General Hospital · 192d
Cleared Sep 09, 2008
VERSAPOD (TM) INSTRUMENT TRAYS
K071783 · KCT
Containmed, Inc.
General Hospital · 435d
Cleared Sep 08, 2008
BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
K081547 · FMF
Bio-Med USA, Inc.
General Hospital · 98d
Cleared Sep 08, 2008
WEIGAO EMPTY CARTRIDGE SYRINGE
K081241 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 130d
Cleared Sep 05, 2008
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
K080531 · KCT
Conmed Linvatec
General Hospital · 192d
Cleared Sep 03, 2008
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · MMK
Zhejiang Gongdong Medical Plastic...
General Hospital · 47d
Cleared Sep 03, 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND...
K081907 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 62d
Cleared Sep 03, 2008
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
K080795 · FYA
Kimberly-Clark Corp.
General Hospital · 167d
Cleared Sep 02, 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · MMK
Global Pathogen Solutions, Inc.
General Hospital · 67d