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
136993–137016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1988
CPE 2000 CARDIO PULMONARY ERGOMETER
K874925 · KRI
Medical Graphics Corp.
Cardiovascular · 48d
Cleared Jan 19, 1988
UNIVERSAL EXAMINATION TABLE
K874934 · KXJ
Imatron, Inc.
Radiology · 46d
Cleared Jan 19, 1988
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
K875077 · BTM
Herco Products, Inc.
Anesthesiology · 41d
Cleared Jan 19, 1988
KODAK KODAFLEX II CASSETTE
K875083 · IXA
Eastman Kodak Company
Radiology · 41d
Cleared Jan 19, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K875157 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 35d
Cleared Jan 19, 1988
ESOPHAGEAL OBTURATOR/TRACHEAL TUBE
K875226 · CAO
Sheridan Catheter Corp.
Anesthesiology · 28d
Cleared Jan 19, 1988
VARIVIEWER (X-RAY FILM VIEWER)
K875233 · IXC
Diversified Diagnostic Products, Inc.
Radiology · 28d
Cleared Jan 19, 1988
MON-A-THERM'S SKIN TEMPERATURE SENSOR
K875234 · FLL
Mon-A-Therm, Inc.
General Hospital · 28d
Cleared Jan 19, 1988
ISOKINETIC SYSTEM, TESTING AND EVALUATION
K875235 · IKK
Orthopedic Systems, Inc.
Physical Medicine · 28d
Cleared Jan 19, 1988
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
K875270 · FMT
Air-Shields, Inc.
General Hospital · 28d
Cleared Jan 15, 1988
SAFETY SHIELD KIT
K873731 · FXX
Ballard Medical Products
General Hospital · 158d
Cleared Jan 14, 1988
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
K871712 · NVE
Machida America, Inc.
General Hospital · 255d
Cleared Jan 14, 1988
DEBRISAN ABSORBENT PAD
K872453 · KOZ
Pharmacia, Inc.
General & Plastic Surgery · 205d
Cleared Jan 14, 1988
PHARMANET (TM)
K872572 · EFQ
Pharmacia, Inc.
General & Plastic Surgery · 199d
Cleared Jan 14, 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · KWA
Osteonics Corp.
Orthopedic · 184d
Cleared Jan 14, 1988
TYMPANIC TEMPERATURE SENSOR
K873205 · FLL
Respiratory Support Products, Inc.
General Hospital · 153d
Cleared Jan 14, 1988
ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)
K873619 · HRX
Arthropedics, Inc.
Orthopedic · 128d
Cleared Jan 14, 1988
M-LENS (THIRTY DEGREE ENDOSCOPE)
K873795 · FEI
Opto Vision, Inc.
Gastroenterology & Urology · 119d
Cleared Jan 14, 1988
MX710 SERIES VASCULAR ACCESS INFUSION SET
K874133 · FPA
Medex, Inc.
General Hospital · 93d
Cleared Jan 14, 1988
HYPODERMIC NEEDLES, SINGLE LUMEN
K874414 · FMI
Harbor Medical Devices, Inc.
General Hospital · 78d
Cleared Jan 14, 1988
DYNAFILM
K874478 · NAD
Ferris Mfg. Corp.
General & Plastic Surgery · 73d
Cleared Jan 14, 1988
MODEL OPO-32 IRRIGATION SLEEVE
K874543 · EIB
Allergan, Inc.
Dental · 72d
Cleared Jan 14, 1988
ACE/FISCHER PERCUTANEOUS HALF PINS
K875012 · JDW
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ACE PERCUTANEOUS 3MM HALF-PINS
K875013 · JDW
Buckman Co., Inc.
Orthopedic · 41d