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
4033–4056 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 16, 2012
ACCU-CHEK ULTRAFLEX INFUSION SET
K122686 · FPA
Roche Diabetes Care AG
General Hospital · 73d
Cleared Nov 16, 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED....
K120066 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 312d
Cleared Nov 15, 2012
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · LJT
C.R. Bard, Inc.
General Hospital · 55d
Cleared Nov 09, 2012
REGEN SPRAY APPLICATOR,
K122122 · FMF
Regen Lab SA
General Hospital · 115d
Cleared Nov 08, 2012
TERUMO(R) NEEDLE
K121607 · FMI
Terumo (Philippines) Corporation
General Hospital · 160d
Cleared Nov 07, 2012
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 47d
Cleared Nov 06, 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · LZA
Northstar Healthcare Holdings
General Hospital · 40d
Cleared Nov 06, 2012
NYLUS PICC
K113225 · LJS
Semprus Biosciences
General Hospital · 371d
Cleared Nov 02, 2012
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
K123267 · FOZ
Kofu Factory of Terumo Corp.
General Hospital · 14d
Cleared Nov 02, 2012
FLO-GUARD BREATHING FILTER
K121026 · CAH
Intersurgical, Inc.
General Hospital · 212d
Cleared Nov 02, 2012
RESUSCITAIRE WITH AUTOBREATH
K120642 · FMT
Draeger Medical Systems, Inc.
General Hospital · 245d
Cleared Oct 26, 2012
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K122215 · FRN
Carticept Medical, Inc.
General Hospital · 93d
Cleared Oct 25, 2012
CLICKFINE PEN NEEDLE
K122971 · FMI
P/L Biomedical
General Hospital · 29d
Cleared Oct 25, 2012
CLICKFINE PEN NEEDLE
K122969 · FMI
P/L Biomedical
General Hospital · 29d
Cleared Oct 25, 2012
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
K121637 · MEG
Sunwell Biotech Co., Ltd.
General Hospital · 143d
Cleared Oct 25, 2012
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
K121594 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 147d
Cleared Oct 19, 2012
3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM)...
K121484 · FRC
3M Company
General Hospital · 154d
Cleared Oct 18, 2012
NMI HPICC III
K122882 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Oct 18, 2012
STERILE BLUNT FOR SINGLE USE
K120420 · FMI
Shanghai Double Dove Industrial Co.,...
General Hospital · 251d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
K113471 · FPA
Nipro Medical Corporation
General Hospital · 331d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · FMI
Nipro Medical Corporation
General Hospital · 331d
Cleared Oct 17, 2012
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131 · LZA
Matang Mfg. Sdn. Bhd.
General Hospital · 91d
Cleared Oct 17, 2012
THS INSTRUMENT TRAY
K120947 · KCT
Hologic, Inc.
General Hospital · 202d
Cleared Oct 17, 2012
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
K120641 · MEG
Global Medi Products
General Hospital · 229d