Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
72145–72168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2003
GLASIONOMER FX-II
K031467 · EMA
Shofu Dental Corp.
Dental · 70d
Cleared Jul 17, 2003
XPECT INFLUENZA A/B
K031565 · PSZ
Remel, Inc.
Microbiology · 59d
Cleared Jul 17, 2003
FERRITIN GENERATION 2
K031650 · DBF
Roche Diagnostics Corp.
Immunology · 50d
Cleared Jul 17, 2003
MENTOR OBTAPE TRANS-OBTURATOR TAPE
K031767 · OTN
Mentor Corp.
Gastroenterology & Urology · 38d
Cleared Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Jul 17, 2003
NATURALASE LP ND:YAG LASER
K031828 · GEN
Focus Medical, LLC
General & Plastic Surgery · 34d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · KHS
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 17, 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 17, 2003
GALT MEDICAL GUIDEWIRE
K031916 · DQX
Galt Medical Corp.
Cardiovascular · 27d
Cleared Jul 17, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA...
K031926 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Jul 17, 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 23d
Cleared Jul 17, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031956 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 22d
Cleared Jul 17, 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · OWB
Philips Medical Systems, Inc.
Radiology · 15d
Cleared Jul 17, 2003
RADIUS 018 COUGAR WIRE
K032129 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 7d
Cleared Jul 16, 2003
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K030960 · FAJ
Acmi Corporation
Gastroenterology & Urology · 111d
Cleared Jul 16, 2003
BIO-LOGIC INSERT EARPHONES
K031352 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · MHX
Ge Medical Systems Information...
Cardiovascular · 76d
Cleared Jul 16, 2003
RUBELLACOL
K031490 · LQN
Immunostics Inc.,
Microbiology · 65d
Cleared Jul 16, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Jul 16, 2003
BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM
K031679 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jul 16, 2003
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
K031890 · JJX
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Jul 16, 2003
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
K032092 · FCL
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 9d
Cleared Jul 15, 2003
SAFETY INTRODUCER NEEDLE
K030135 · DYB
B.Braun Medical, Inc.
Cardiovascular · 182d