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
122065–122088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1991
MODIFIED PYROGEN TESTING
K910935 · DTM
Electromedics, Inc.
Cardiovascular · 91d
Cleared May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · DQX
Terumo Corp.
Cardiovascular · 71d
Cleared May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 15, 1991
BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS
K902968 · DZE
Core-Vent Corp.
Dental · 313d
Cleared May 15, 1991
FOUNDATION HYBRID COMPOSITE
K904135 · EBD
Nulite Systems Research
Dental · 251d
Cleared May 15, 1991
MODEL STT-100
K904853 · IYO
Sonocare, Inc.
Radiology · 198d
Cleared May 15, 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · IZI
GE Medical Systems
Radiology · 148d
Cleared May 15, 1991
SONOPAK/QS, SONOPAK
K905657 · NFQ
Bioresearch
Dental · 149d
Cleared May 15, 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · KGI
Hologic, Inc.
Radiology · 147d
Cleared May 15, 1991
CLEARVIEW HCG SERUM/URINE
K905741 · JHI
Unipath , Ltd.
Chemistry · 142d
Cleared May 15, 1991
URODYNAMIC MEASURING SYSTEM
K910371 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 106d
Cleared May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
K910617 · DDF
Organon Teknika Corp.
Immunology · 92d
Cleared May 15, 1991
TOTAL BILIRUBIN REAGENT SET
K910635 · CIG
Biochemical Trade, Inc.
Chemistry · 92d
Cleared May 15, 1991
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781 · ETF
Midmark Corp.
Ear, Nose, Throat · 79d
Cleared May 15, 1991
TASSI MK3 (TURNAIR)
K910851 · IOQ
Therapy Air Support Systems, Inc.
Physical Medicine · 76d
Cleared May 15, 1991
PROTEKT GLOVES
K910920 · FYE
Intermedics Orthopedics
General & Plastic Surgery · 71d
Cleared May 15, 1991
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
K911068 · EFB
Micro Motors, Inc.
Dental · 65d
Cleared May 15, 1991
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
K911072 · EHZ
A & F Products
Dental · 65d
Cleared May 15, 1991
MERCURY AND GLASS FEVER THERMOMETER
K911269 · FLK
Steridyne Corp.
General Hospital · 54d
Cleared May 15, 1991
PULPDENT PIC N STIC
K911281 · EKJ
Pulpdent Corp.
Dental · 57d
Cleared May 15, 1991
BUFFING FLOSS
K911470 · JES
Lamar Industries
Dental · 42d
Cleared May 15, 1991
TOKUSO LIGHT BOND
K911525 · KLE
Tokuyama America, Inc.
Dental · 40d
Cleared May 15, 1991
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
K911558 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 37d
Cleared May 15, 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · CHH
Cholestech Corp.
Chemistry · 49d