FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89257–89280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1998
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
K981576 · MHX
Hewlett-Packard GmbH
Cardiovascular · 74d
Cleared Jul 17, 1998
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR
K981602 · BTA
Sunrise Medical Hhg, Inc.
General & Plastic Surgery · 73d
Cleared Jul 17, 1998
NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/...
K981614 · GEI
Aaron Medical Industries
General & Plastic Surgery · 72d
Cleared Jul 17, 1998
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST,...
K981641 · IZH
Instrumentarium Corp.
Radiology · 70d
Cleared Jul 17, 1998
RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
K981672 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 66d
Cleared Jul 17, 1998
EXTERNAL FIXATION
K981716 · JDW
Avanta Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jul 17, 1998
DORNIER MEDILAS H
K981718 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 63d
Cleared Jul 17, 1998
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · LBB
Nk Biotechnical Corp.
Neurology · 63d
Cleared Jul 17, 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
K981745 · DRS
Sunscope Intl., Inc.
Cardiovascular · 60d
Cleared Jul 17, 1998
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · JDO
Synthes (Usa)
Orthopedic · 59d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · LZO
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jul 17, 1998
AMBU TUBECHECK
K981891 · BTR
Ambu, Inc.
Anesthesiology · 49d
Cleared Jul 17, 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW...
K981967 · MBI
Arthrotek/Biomet, Inc.
Orthopedic · 43d
Cleared Jul 17, 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY...
K982085 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 32d
Cleared Jul 16, 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS...
K972700 · KHJ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 393d
Cleared Jul 16, 1998
KNIGHTSTAR 335
K973004 · MNT
Puritan Bennett Corp.
Anesthesiology · 337d
Cleared Jul 16, 1998
CPR FILTERSHIELD
K980066 · BTM
Plasco, Inc.
Anesthesiology · 190d
Cleared Jul 16, 1998
OSCILLOMATE NIBP / SP02 EMS MONITOR
K980879 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 129d
Cleared Jul 16, 1998
EQUINOXE
K980920 · ILJ
Bouvier Hydro, Inc.
Physical Medicine · 128d
Cleared Jul 16, 1998
SYNERGY LT
K981405 · GWF
Oxford Instruments, Plc.
Neurology · 87d
Cleared Jul 16, 1998
CERVIX COIL LATEX SHEATH
K981406 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 87d
Cleared Jul 16, 1998
LC POSITIONER
K981414 · JAA
Fischer Imaging Corp.
Radiology · 87d
Cleared Jul 15, 1998
FLOW-EZE BLUNT CANNULA (1999BC)
K972538 · FMI
Acacia, Inc.
General Hospital · 372d
Cleared Jul 15, 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 359d