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
159529–159552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1982
SKIN SCRUB-TRAY
K821579 · LDR
Associated Medical Products Co.
General Hospital · 54d
Cleared Jul 21, 1982
PREGNOPOST
K821621 · KDT
M.M. Wolfred, Ph.D.
Chemistry · 49d
Cleared Jul 21, 1982
DYNACOR URETHRAL CATHETER TRAY
K821970 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 20, 1982
LDH-UV REAGENT SET
K821201 · CFJ
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
TRIGLYCERIDE REAGENT SET
K821205 · CDT
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
SGOT-UV REAGENT SET
K821208 · CIT
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
THE SPORTS HAND
K821619 · IRA
Therapeutic Recreation Systems, Inc.
Physical Medicine · 48d
Cleared Jul 20, 1982
MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
K821695 · HTT
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 42d
Cleared Jul 20, 1982
BEACH ANESTHETIC SYRINGE CARTR. TYPE
K821782 · EJI
Pacific Dental Corp.
Dental · 33d
Cleared Jul 20, 1982
MILBURN'S BACKEASER
K821808
The T. Milburn Co. , Ltd.
Physical Medicine · 32d
Cleared Jul 20, 1982
GENTLE-LIFT CHAIR
K821827 · INO
Pride Health Care Equipment
Physical Medicine · 28d
Cleared Jul 20, 1982
HI-LO TEMP SKIN TEMPERATURE SENSOR
K821833 · FLL
Mallinckrodt Critical Care
General Hospital · 28d
Cleared Jul 20, 1982
VARI-SUPPORT NECK POSTURE PILLOW
K821837 · IQK
Body Therapeutics, Inc.
Physical Medicine · 28d
Cleared Jul 20, 1982
VARI-SUPPORT LOW BACK POSTURE PILLOW
K821838 · CCX
Body Therapeutics, Inc.
Anesthesiology · 28d
Cleared Jul 20, 1982
DISPOSABLE TRANSDUCER DOMES & KITS
K821894 · DRS
American Pharmaseal Div. Ahsc
Cardiovascular · 22d
Cleared Jul 20, 1982
DISC-O-AID
K821903 · IKX
M. Dahm International Aps
Physical Medicine · 22d
Cleared Jul 20, 1982
BIURET (COLORIMETRIC) TOTAL PROTEIN
K821905 · CEK
American Monitor Corp.
Chemistry · 22d
Cleared Jul 20, 1982
BIO-CAL OPERATION CHECK KIT
K821934 · JIS
Bio-Analytics Laboratories, Inc.
Chemistry · 21d
Cleared Jul 20, 1982
ALT ENZYME ASSAY KIT
K821946 · CKA
Travenol Laboratories, S.A.
Chemistry · 20d
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K821950 · DIF
Travenol Laboratories, S.A.
Toxicology · 20d
Cleared Jul 20, 1982
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · DRT
Electromed Intl., Ltd.
Cardiovascular · 20d
Cleared Jul 20, 1982
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K821965 · LAT
Immunalysis Corporation
Chemistry · 18d
Cleared Jul 20, 1982
VALULINE* AMALGAM ALLOY
K821971 · EJJ
Johnson & Johnson Professionals, Inc.
Dental · 14d
Cleared Jul 20, 1982
HEARING AID VARIOUS MODELS
K821972 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 18d