FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98449–98472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1996
A2 DETACHED DUAL PORT SYSTEM
K955819 · LJT
Arrow Intl., Inc.
General Hospital · 86d
Cleared Mar 21, 1996
ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)
K955838 · NPK
Atrix Laboratories, Inc.
Dental · 90d
Cleared Mar 21, 1996
DISCOGRAPHY KIT
K960082 · IZG
Spinal Specialties, Inc.
Radiology · 70d
Cleared Mar 21, 1996
ENDOSCOPIC ACCESS DEVICE
K960232 · GCJ
Applied Medical Technologies
General & Plastic Surgery · 64d
Cleared Mar 21, 1996
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
K960426 · GBW
Medical Components, Inc.
General & Plastic Surgery · 52d
Cleared Mar 21, 1996
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)
K960428 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 69d
Cleared Mar 21, 1996
LACERATION TRAY
K960520 · FRG
Medco Instruments, Inc.
General Hospital · 44d
Cleared Mar 21, 1996
SSA-340A (MODIFICATION)
K960602 · IYN
Toshiba America Medical Systems, In.C
Radiology · 65d
Cleared Mar 21, 1996
MAXCESS NEEDLE FREE CONNECTOR (8200)
K960661 · FPA
Solopak Medical Products, Inc.
General Hospital · 34d
Cleared Mar 21, 1996
CONMED SELECT ONE LAPAROSCOPY ELECTRODE
K960808 · GEI
Conmedcorp
General & Plastic Surgery · 22d
Cleared Mar 20, 1996
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · GQX
Light Diagnostics
Microbiology · 336d
Cleared Mar 20, 1996
EPIX XL TENS UNIT
K951903 · GZJ
Empi
Neurology · 331d
Cleared Mar 20, 1996
CPR MICROMASK WITH OXYGEN INLET
K953414 · CBP
Plasco, Inc.
Anesthesiology · 244d
Cleared Mar 20, 1996
SPACELINE FEEL 21
K953865 · EFA
J. Morita USA, Inc.
Dental · 216d
Cleared Mar 20, 1996
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · FRN
Imed Corp.
General Hospital · 216d
Cleared Mar 20, 1996
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · LRM
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · LLL
Hycor Biomedical, Inc.
Immunology · 183d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KIT (JO-1)
K954895 · LLL
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
K955164 · FMF
Habley Medical Technology Corp.
General Hospital · 128d
Cleared Mar 20, 1996
LXN FRUCTOSAMINE TEST
K955629 · JJX
Lxn Corp.
Chemistry · 100d
Cleared Mar 20, 1996
REMOVABLE HERBST APPLIANCE
K955822 · LRK
Univ. Dental Assoc. Department of...
Dental · 85d
Cleared Mar 20, 1996
ORTHOFIX MODULSYSTEM
K955848 · JDW
Orthofix, Inc.
Orthopedic · 84d