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
5809–5832 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 15, 2006
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · FXX
Dukal Corp.
General Hospital · 74d
Cleared Sep 15, 2006
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K061662 · LYZ
Tangshan Luxiong Plastic Products...
General Hospital · 95d
Cleared Sep 15, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K061659 · LYZ
Tangshan Luxiong Plastic Products...
General Hospital · 95d
Cleared Sep 14, 2006
VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
K052475 · LJS
Vygon Us, LLC
General Hospital · 370d
Cleared Sep 13, 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092 · FMF
Micromedics, Inc.
General Hospital · 147d
Cleared Sep 08, 2006
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K062522 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 11d
Cleared Sep 06, 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · LZA
Shen Wei (Usa), Inc.
General Hospital · 47d
Cleared Sep 05, 2006
IMAX 9.5 STERILIZERS
K052532 · FLE
Dental X Srl
General Hospital · 355d
Cleared Aug 29, 2006
V-808 ATOM TRANSCAPSULE
K061071 · FPL
Atom Medical, Inc.
General Hospital · 134d
Cleared Aug 25, 2006
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
K061738 · JOJ
Albert Browne , Ltd.
General Hospital · 66d
Cleared Aug 24, 2006
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN...
K061551 · LYY
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 80d
Cleared Aug 24, 2006
BODYGAURD PAIN MANAGER INFUSION SYSTEM
K061325 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 105d
Cleared Aug 24, 2006
ARROW PRESSURE INJECTABLE PICC
K061289 · LJS
Arrow International, Inc.
General Hospital · 107d
Cleared Aug 24, 2006
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510,...
K061194 · MEG
Smiths Medical Asd, Inc.
General Hospital · 118d
Cleared Aug 23, 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · FMF
Wrightmedicaltechnologyinc
General Hospital · 23d
Cleared Aug 17, 2006
PEDI-SPIDER STRAP
K061721 · NZD
Emergency Products and Research
General Hospital · 59d
Cleared Aug 14, 2006
PRESTIGE AMERITECH FACE MASK
K061716 · FXX
Prestige Ameritech
General Hospital · 56d
Cleared Aug 14, 2006
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
K061483 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 76d
Cleared Aug 11, 2006
SAFETY SYRINGE
K053519 · MEG
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 235d
Cleared Aug 09, 2006
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
K061936 · LJS
The Kendall Company
General Hospital · 30d
Cleared Aug 09, 2006
LAC-MAC INNERBLOC O.R. GOWN
K061491 · FYA
Lac Mac, Ltd.
General Hospital · 70d
Cleared Aug 09, 2006
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
K061179 · LJS
C.R. Bard, Inc.
General Hospital · 104d
Cleared Aug 08, 2006
COMCASET SAFETY IV CATHETER
K062108 · FOZ
Pitango Medical, Ltd.
General Hospital · 15d
Cleared Aug 04, 2006
VERSALET 7700 CARE CENTER
K053399 · FMZ
Draeger Medical Infant Care, Inc.
General Hospital · 241d