FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
104665–104688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1995
KENLOR HUMAN SPINAL FLUID CONTROL
K950326 · JJY
Kenlor Industries, Inc.
Chemistry · 61d
Cleared Mar 20, 1995
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
K950589 · JJX
Creative Laboratory Products, Inc.
Chemistry · 39d
Cleared Mar 20, 1995
AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830
K951037 · IOR
Akisu Machinery
Physical Medicine · 13d
Cleared Mar 20, 1995
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · IOR
Invacare Corp.
Physical Medicine · 7d
Cleared Mar 17, 1995
TRIP CIC CATHETER
K920849 · FFT
Tonometrics, Inc.
Gastroenterology & Urology · 1116d
Cleared Mar 17, 1995
ESOPHAGEAL STETHOSCOPE
K930929 · BZT
Coast Medical Corp.
Anesthesiology · 752d
Cleared Mar 17, 1995
PARI-MASTER MODIFICATION
K935540 · CAF
Pari Holding Co.
Anesthesiology · 486d
Cleared Mar 17, 1995
LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
K942381 · DXT
Apogee, Inc.
Cardiovascular · 302d
Cleared Mar 17, 1995
VACSTAR
K942698 · EIA
Air Techniques, Inc.
Dental · 282d
Cleared Mar 17, 1995
CONQUEST MALE CONTINENCE SYSTEM
K942941 · EXJ
Convatec, A Bristol-Myers Squibb Co.
Gastroenterology & Urology · 268d
Cleared Mar 17, 1995
SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM
K943389 · CCK
Hewlett-Packard Co.
Anesthesiology · 246d
Cleared Mar 17, 1995
PEGASUS BIWAVE PLUS SYSTEM
K944310 · FNM
Pegasus Airwave, Inc.
General Hospital · 196d
Cleared Mar 17, 1995
PULSE GUARD 3FR ELECTRODE
K944571 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 179d
Cleared Mar 17, 1995
FLEXSYS MOBILEMATE EQUIPMENT STAND
K944580 · FOX
Hill-Rom, Inc.
General Hospital · 179d
Cleared Mar 17, 1995
ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE
K945087 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 151d
Cleared Mar 17, 1995
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · JWY
Ab Biodisk
Microbiology · 144d
Cleared Mar 17, 1995
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
K945691 · MEH
Osteonics Corp.
Orthopedic · 116d
Cleared Mar 17, 1995
SCIMED(R) ENTRE PTCA GUIDE WIRE
K946180 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1995
3301T OXITEMP
K946185 · DQA
Bci Intl., Inc.
Anesthesiology · 87d
Cleared Mar 17, 1995
DRUG DISPENSING SPIKE
K946190 · FMF
Gelman Sciences, Inc.
General Hospital · 87d
Cleared Mar 17, 1995
TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER
K946313 · HRX
Smith and Nephew Donjoy, Inc.
Orthopedic · 79d
Cleared Mar 17, 1995
KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR
K950358 · IXW
Storch Amini & Munves PC
Radiology · 49d
Cleared Mar 17, 1995
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729 · ODD
Olympus America, Inc.
Gastroenterology & Urology · 29d
Cleared Mar 16, 1995
FORTE ES
K940759 · GZI
Chattanooga Group, Inc.
Neurology · 391d