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
104713–104736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1995
MODEL 528GE SERIES
K944331 · LNH
Medical Advances, Inc.
Radiology · 141d
Cleared Jan 25, 1995
GENERAL PURPOSE FLEX COIL
K944469 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 138d
Cleared Jan 25, 1995
FLEXART QD BODY COIL
K944662 · LNH
Toshiba America Mri, Inc.
Radiology · 126d
Cleared Jan 25, 1995
MODEL 405GE-64: PHASED ARRAY TMJ COIL
K944773 · LNH
Medical Advances, Inc.
Radiology · 120d
Cleared Jan 25, 1995
MODEL 792 CONVERGE, MODEL 793 VISION 2000
K945431 · FPO
Hausted, Inc.
General Hospital · 163d
Cleared Jan 25, 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED,...
K945692 · GKZ
Dako Corp.
Hematology · 65d
Cleared Jan 25, 1995
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
K945788 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared Jan 25, 1995
MICROLINE SCREEN FOR BENZODIAZEPINE
K945829 · JXM
Drug Screening Systems, Inc.
Toxicology · 57d
Cleared Jan 25, 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · DKJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 24, 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · GGP
Behring Diagnostics, Inc.
Hematology · 875d
Cleared Jan 24, 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 673d
Cleared Jan 24, 1995
STERIL-DERM-PLUS TRANSPARENT DRESSING
K931766 · FRO
Biointerface Technologies, Inc.
General & Plastic Surgery · 656d
Cleared Jan 24, 1995
CYBERRX MODEL 7200
K934434 · FFT
Cybermed Control Systems, Inc.
Gastroenterology & Urology · 519d
Cleared Jan 24, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K934692 · MKJ
Katecho, Inc.
Cardiovascular · 481d
Cleared Jan 24, 1995
BALLOON DILATION CATHETER
K935094 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 459d
Cleared Jan 24, 1995
THE KARL STORZ HAMOU ENDOMAT
K936231 · HIG
Karl Storz Endoscopy
Obstetrics & Gynecology · 391d
Cleared Jan 24, 1995
COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE
K940145 · IYE
Huestis Machine Corp.
Radiology · 386d
Cleared Jan 24, 1995
YASARGIL, CASPAR, VARIO CLIP APPLIERS
K940970 · HCI
Aesculap, Inc.
Neurology · 328d
Cleared Jan 24, 1995
MONOPOLAR SUCTION CANNULA
K941207 · KNF
New Eder Corp.
Obstetrics & Gynecology · 316d
Cleared Jan 24, 1995
UTERINE INJECTOR WITH SPRING
K941457 · LKF
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 305d
Cleared Jan 24, 1995
WARM AIR WARMING UNIT
K942599 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 237d
Cleared Jan 24, 1995
DIGITAL HOLTER RECORDER
K942781 · DSH
Agilent Technologies
Cardiovascular · 225d
Cleared Jan 24, 1995
WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
K942790 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 225d
Cleared Jan 24, 1995
STRYKER POWERED STRETCHER
K942948 · FPO
Stryker Corp.
General Hospital · 215d