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
73057–73080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2002
PORTADUR P2
K023395 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 63d
Cleared Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
K023597 · LTK
Beckman Coulter, Inc.
Immunology · 44d
Cleared Dec 11, 2002
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153,...
K023777 · HRX
Arthronet Medical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · DTB
Biotronik, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · DWF
Ethicon, Inc.
Cardiovascular · 20d
Cleared Dec 11, 2002
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · KNW
Senorx, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 11, 2002
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS...
K023928 · JJW
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 11, 2002
GE PHOTON ENERGY RECOVERY (PER) OPTION
K023932 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 15d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296 · KWP
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Dec 10, 2002
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · MNH
Sintea Biotech, Inc.
Orthopedic · 334d
Cleared Dec 10, 2002
BD DIRECTIGEN EZ RSV KIT
K022133 · GQG
Becton, Dickinson & CO
Microbiology · 162d
Cleared Dec 10, 2002
SNORE-AID MAX
K022284 · LRK
Dental Imagineers, LLC
Dental · 148d
Cleared Dec 10, 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...
K022377 · KWT
Implex Corp.
Orthopedic · 141d
Cleared Dec 10, 2002
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
K023019 · FGI
Vomed Volzer Medizintechnik GmbH & Co.
Gastroenterology & Urology · 90d
Cleared Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
K023077 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 85d
Cleared Dec 10, 2002
SMARTSTEP SYSTEM
K023161 · IRN
Andante Medical Device, Ltd.
Physical Medicine · 78d
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320 · DQY
Guidant Corp.
Cardiovascular · 67d
Cleared Dec 10, 2002
BIOPORTA G
K023391 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 62d
Cleared Dec 10, 2002
VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
K023469 · FPA
Victus, Inc.
General Hospital · 55d
Cleared Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K023732 · LPL
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 10, 2002
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · JIX
Ortho-Clinical Diagnostics, Inc.
Toxicology · 19d