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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161929–161952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1981
KT-1000 DEVICE
K812806 · LYH
Medmetric Corp.
Neurology · 35d
Cleared Nov 10, 1981
NEUTRAL DUFFERED FORMA-SCENT
K812817 · IFP
Meridian Diagnostics, Inc.
Pathology · 34d
Cleared Nov 10, 1981
CHANG MEDIUM
K812820 · KIT
Hana Biologics, Inc.
Pathology · 34d
Cleared Nov 10, 1981
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · JJQ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 10, 1981
SYRINGE, PISTON
K812888 · FMF
Frisco Products, Inc.
General Hospital · 26d
Cleared Nov 10, 1981
ACUPRESS VIBRATOR
K812902 · IRO
Eicona Corp.
Physical Medicine · 25d
Cleared Nov 10, 1981
DSD
K812983 · JQW
Pm America, Inc.
Chemistry · 15d
Cleared Nov 10, 1981
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK
K812993 · JTN
General Diagnostics
Microbiology · 15d
Cleared Nov 10, 1981
PROTECT-O-SEAL
K813014 · JOJ
Tri-Med, Inc.
General Hospital · 14d
Cleared Nov 10, 1981
STANDING FRAME
K813025
Barnett Medical
Physical Medicine · 13d
Cleared Nov 10, 1981
ULTRACHEM TP, ITEM #64974
K813038 · CEK
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM E-CHOL, ITEM #65025
K813039 · CHH
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CA, ITEM #64975
K813040 · CJY
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · JQB
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
K813042 · LFR
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CREA ITEM #64972
K813043 · CGX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
K813044 · CIX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
E2508 DISPOSABLE HANDSWITCHING PENCIL
K813071 · GEI
Valleylab, Inc.
General & Plastic Surgery · 8d
Cleared Nov 10, 1981
E2502 & E2502B LECTROSWITCH
K813072 · GEI
Valleylab, Inc.
General & Plastic Surgery · 8d
Cleared Nov 06, 1981
PERSONAL MEDICATION INFUSER
K810850 · FRN
Pacesetter Systems
General Hospital · 221d
Cleared Nov 06, 1981
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 101d
Cleared Nov 06, 1981
MODEL RS 8300
K812230 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 06, 1981
HEALTH-UP
K812432 · GZJ
Wfx Industries, Inc.
Neurology · 73d
Cleared Nov 06, 1981
CLOTH SURGICAL GLOVES
K812735 · KGO
Medical Synergy
General Hospital · 38d