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
131041–131064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1989
TRUVEL TZ-3X X-RAY DIGITIZING SCANNER
K890970 · LMA
Truvel Corp.
Radiology · 73d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVE
K890975 · LYY
Kleartex Sdn Bhd
General Hospital · 73d
Cleared May 11, 1989
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · FPK
3M Company
General Hospital · 72d
Cleared May 11, 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148 · DSI
Del Mar Avionics
Cardiovascular · 69d
Cleared May 11, 1989
NEWPORT LATERAL VAGINAL RETRACTOR
K891351 · KOH
Simpson/Basye, Inc.
Obstetrics & Gynecology · 62d
Cleared May 11, 1989
RETRACTOR RODS
K891398 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 58d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX) (POWDERED)
K891428 · LYY
Bio-Aid Industries Sdn Bhd
General Hospital · 58d
Cleared May 11, 1989
OBSTETRIC CUP (MODIFICATION)
K891465 · HDB
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 57d
Cleared May 11, 1989
FIRST AID SURVIVAL KIT
K891483 · LRR
Elwyn, Inc.
General & Plastic Surgery · 55d
Cleared May 11, 1989
MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
K891541 · LNH
Diasonics, Inc.
Radiology · 55d
Cleared May 11, 1989
ORAL AIRWAY
K891586 · CAE
Dynarex Corp.
Anesthesiology · 52d
Cleared May 11, 1989
MODEL 2030
K891598 · LNH
Medical Advances, Inc.
Radiology · 52d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891630 · LYY
Inter-Continental Industries Sdn Bhd
General Hospital · 55d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891717 · LYZ
Ulti-Med Intl., Inc.
General Hospital · 51d
Cleared May 11, 1989
MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES
K891775 · EJF
American Orthodontics
Dental · 48d
Cleared May 11, 1989
ARGEDENT 52SF
K891911 · EJT
Argen Precious Metals, Inc.
Dental · 45d
Cleared May 11, 1989
THERMOMAX MICROPLATE READER, MODIFICATION
K892063 · JJQ
Molecular Devices Corp.
Chemistry · 42d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892128 · LYY
Excel U.S.A.
General Hospital · 36d
Cleared May 11, 1989
GE SHOULDER SURFACE COIL, CAT. #M1085AN
K892235 · LNH
General Electric Co.
Radiology · 37d
Cleared May 11, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892272 · LYY
Wagania Sdn. Bhd.
General Hospital · 36d
Cleared May 11, 1989
PATIENT EXAM GLOVES (MFG. AMERICAN RUBBER PRODUCT)
K892291 · LYY
American Health Products, Inc.
General Hospital · 35d
Cleared May 11, 1989
DRUGS OF ABUSE URINE CALIBRATORS
K892332 · DKB
Hycor Biomedical, Inc.
Toxicology · 36d
Cleared May 11, 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523 · FJI
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared May 11, 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · NAD
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 30d