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
137065–137088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1988
ORTHOMET PIN SYSTEM
K874913 · HTY
Orthomet, Inc.
Orthopedic · 35d
Cleared Jan 07, 1988
ORTHOMET WIRE FOR SUTURE, CERCLAGE
K874919 · JDQ
Orthomet, Inc.
Orthopedic · 35d
Cleared Jan 07, 1988
IN-THE-EAR HEARING AID
K875009 · ESD
House of Hearing Aids, Ltd.
Ear, Nose, Throat · 34d
Cleared Jan 07, 1988
ORTHOMET BONE SCREWS
K875050 · HWC
Orthomet, Inc.
Orthopedic · 30d
Cleared Jan 07, 1988
DEGANIA SILICONE TOURNIQUET
K875092 · GAX
Degania Silicone , Ltd.
General & Plastic Surgery · 28d
Cleared Jan 06, 1988
MODEL 3000 INFUSION PUMP
K871881 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 237d
Cleared Jan 06, 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · DPS
Del Mar Avionics
Cardiovascular · 183d
Cleared Jan 06, 1988
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
K872928 · DQK
Fidelity Medical, Inc.
Cardiovascular · 163d
Cleared Jan 06, 1988
DISPOSABLE I.V. ADMINISTRATION SET
K872953 · FPA
Mac Lee Medical Products
General Hospital · 161d
Cleared Jan 06, 1988
ULTRASPOT MICROMANIPULATOR
K873443 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 132d
Cleared Jan 06, 1988
ROPER-TUKE ELBOW
K873660 · JDB
Orthopedic Systems, Inc.
Orthopedic · 118d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · CAK
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873667 · CAK
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Jan 06, 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · FRN
Baxter Healthcare Corp
General Hospital · 112d
Cleared Jan 06, 1988
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
K873748 · GDW
Deknatel, Inc.
General & Plastic Surgery · 112d
Cleared Jan 06, 1988
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K873884 · FRN
Y
General Hospital · 105d
Cleared Jan 06, 1988
SET, ADMINISTRATION INTRAVASCULAR
K874467 · FPA
Kendall Mcgaw Laboratories, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED AIRWAY TEMPERATURE SENSOR
K874520 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED THERMAL WELL TEMPERATURE SENSOR
K874521 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
K874523 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
K874524 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
K874525 · KOD
Mon-A-Therm, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 06, 1988
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · FLL
Mallinckrodt Critical Care
General Hospital · 62d
Cleared Jan 06, 1988
ZEISS VISULAS ARGON LASER
K874609 · HQF
Carl Zeiss, Inc.
Ophthalmic · 58d