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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89473–89496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1998
EXEL AVF SINGLE NEEDLE
K963658 · FMI
Exel Intl.
General Hospital · 609d
Cleared May 05, 1998
OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
K972020 · DXW
Cas Medical Systems, Inc.
Cardiovascular · 337d
Cleared May 05, 1998
BIOMET BIAXIAL TOTAL ELBOW
K980428 · JDC
Biomet, Inc.
Orthopedic · 90d
Cleared May 05, 1998
JOBST ATHROMBIC PUMP SYSTEM 2600
K980456 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 89d
Cleared May 05, 1998
ONPLANT ORTHODONTIC SYSTEM
K980460 · DZE
Nobel Biocare Uas, Inc.
Dental · 92d
Cleared May 05, 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · JDC
Osteonics Corp.
Orthopedic · 85d
Cleared May 05, 1998
OSTEONICS FX-CABLELOK GRIP COMPONENTS
K980594 · LYT
Osteonics Corp.
Orthopedic · 77d
Cleared May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T...
K980417 · LNH
Medrad, Inc.
Radiology · 90d
Cleared May 04, 1998
LIGHTSHEER
K980420 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared May 04, 1998
SYNTEC VITMAN
K980480 · HQC
Syntec, Inc.
Ophthalmic · 90d
Cleared May 04, 1998
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · GAW
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared May 04, 1998
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
K980777 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 63d
Cleared May 04, 1998
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
K980827 · LZB
Tucker & Associates
General Hospital · 62d
Cleared May 01, 1998
GLASS VAN GLASS SYRINGES
K963364 · FMF
Myco Medical Supplies, Inc.
General Hospital · 613d
Cleared May 01, 1998
B-D ASSURE EAR THERMOMETER
K971994 · FLL
Becton Dickinson Consumer Products
General Hospital · 337d
Cleared May 01, 1998
CMVGEN
K974456 · LJO
Instrumentation Laboratory CO
Microbiology · 157d
Cleared May 01, 1998
BIO-POST DENTAL POST SYSTEM
K974649 · ELR
Advanced Aeromedical, Inc.
Dental · 140d
Cleared May 01, 1998
COAMATIC PLASMINOGEN
K974711 · GGP
Instrumentation Laboratory CO
Hematology · 135d
Cleared May 01, 1998
BACTEC MGIT 960 SYSTEM
K974883 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 122d
Cleared May 01, 1998
BRONCHIAL CATHETER SYSTEM
K980046 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 115d
Cleared May 01, 1998
OAC (OPTICAL ASPIRATING CURETTE)
K980096 · HCY
Imagyn Medical Technologies, Inc.
Obstetrics & Gynecology · 112d
Cleared May 01, 1998
IMMULITE ANTI-TG AB
K980206 · JZO
Diagnostic Products Corp.
Immunology · 101d
Cleared May 01, 1998
TRIP TONOMETRY CATHETER, 18F
K980384 · CCK
Datex-Engstrom, Inc.
Anesthesiology · 88d
Cleared May 01, 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR...
K980385 · DSP
Datascope Corp.
Cardiovascular · 88d