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
141097–141120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1987
LINEN (HUCK) TOWEL
K865094 · KKX
The Eye Co-Op, Inc.
General Hospital · 21d
Cleared Jan 20, 1987
ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES
K865095 · EFQ
Kor-Medical Industries, Ltd.
General & Plastic Surgery · 21d
Cleared Jan 20, 1987
AIMED GAUZE SPONGE
K865097 · EFQ
Kor-Medical Industries, Ltd.
General & Plastic Surgery · 21d
Cleared Jan 20, 1987
KROM-X LENS SYSTEM
K865103 · HQG
Neo Optics, Inc.
Ophthalmic · 21d
Cleared Jan 20, 1987
CHARTER HARD CONTACT LENS CLEANING SOLUTION
K865111 · HPX
Paco Pharmaceutical Services, Inc.
Ophthalmic · 20d
Cleared Jan 16, 1987
40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON
K863185 · DSP
Aries Medical, Inc.
Cardiovascular · 150d
Cleared Jan 16, 1987
REFURBISH DIAGNOSTIC X-RAY EQUIPMENT
K863309 · KPR
Chemarts and Assoc., Inc.
Radiology · 142d
Cleared Jan 16, 1987
FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
K864000 · DXO
Fiberoptic Sensor Technlogies, Inc.
Cardiovascular · 94d
Cleared Jan 16, 1987
PERCUPUMP (TM)
K864227 · FRN
E-Z-Em, Inc.
Radiology · 80d
Cleared Jan 16, 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · DTB
Intermedics, Inc.
Cardiovascular · 73d
Cleared Jan 16, 1987
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
K864393 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 71d
Cleared Jan 16, 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437 · DBF
Beckman Instruments, Inc.
Immunology · 65d
Cleared Jan 15, 1987
AML II TITANIUM ACETABULUM PROSTHESIS
K861979 · JDI
Depuy, Inc.
Orthopedic · 239d
Cleared Jan 15, 1987
PROFILE HIP ACETABULUM PROSTHESIS
K863184 · JDI
Depuy, Inc.
Orthopedic · 149d
Cleared Jan 15, 1987
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420 · CCJ
Vitalograph , Ltd.
Anesthesiology · 133d
Cleared Jan 15, 1987
CART, ORTHOPEDIC BED, STRYKER
K863685 · FNJ
Brenner Metal Prod Corp.
General Hospital · 118d
Cleared Jan 15, 1987
SPIROMETRICS MODEL 2500 FLOWMATE(TM)
K863953 · BZM
Spirometrics, Inc.
Anesthesiology · 97d
Cleared Jan 15, 1987
MA-2 AND MA2+2 VOLUME VENTILATORS
K864430
Puritan Bennett Corp.
Anesthesiology · 64d
Cleared Jan 15, 1987
ANESTHESIA RECORDER
K864806 · BSZ
Draeger Medical, Inc.
Anesthesiology · 37d
Cleared Jan 15, 1987
VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
K864822 · BTC
Surgidyne, Inc.
Anesthesiology · 37d
Cleared Jan 15, 1987
SPIROVISION
K864885 · BZM
Futuremed Div. of Future Impex Corp.
Anesthesiology · 34d
Cleared Jan 15, 1987
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K865046 · BZA
Salter Labs
Anesthesiology · 22d
Cleared Jan 15, 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · BTO
Shiley, Inc.
Anesthesiology · 22d
Cleared Jan 15, 1987
SAFE-T-SHIELD MOUTHPIECE
K865093 · BYP
Medi Nuclear Corp., Inc.
Anesthesiology · 16d