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
87601–87624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · LKO
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · LKP
Bio-Rad
Immunology · 6d
Cleared Dec 21, 1998
INSIGHT DIAGNOSTIC IMAGING WORKSTATION
K982535 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 154d
Cleared Dec 21, 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · LYY
Vitalcare Group, Inc.
General Hospital · 126d
Cleared Dec 21, 1998
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K983342 · LHN
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Dec 21, 1998
MODEL MS-1 HANDPIECE
K983413 · EKX
Parkell, Inc.
Dental · 84d
Cleared Dec 21, 1998
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · DZL
Synthes (Usa)
Dental · 77d
Cleared Dec 21, 1998
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM...
K983568 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 69d
Cleared Dec 21, 1998
GIFT CATHETER SET/S
K983590 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
INTRATUBAL TRANSFER SETS
K983591 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
EMBRYO TRANSFER CATHETERS/SETS
K983594 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 69d
Cleared Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · JIS
Beckman Coulter, Inc.
Chemistry · 66d
Cleared Dec 21, 1998
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
K983731 · EIA
Pall Medical
Dental · 60d
Cleared Dec 21, 1998
PHILIPS INTEGRIS 3D RA OPTION
K983877 · IZI
Philips Medical Systems North...
Radiology · 49d
Cleared Dec 21, 1998
MIR SPIROBANK SPIROMETER
K983909 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 48d
Cleared Dec 21, 1998
OWEN MUMFORD 3ML AUTOPEN
K983974 · FMF
Owen Mumford USA, Inc.
General Hospital · 42d
Cleared Dec 18, 1998
NUVO BARRIER FILM
K980117 · KMF
Biomedical Development Co.
General & Plastic Surgery · 339d
Cleared Dec 18, 1998
CD SPINAL SYSTEM
K980184 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Dec 18, 1998
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · FGE
Cordis Corp.
Gastroenterology & Urology · 290d
Cleared Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · HCI
Johnson & Johnson Professionals, Inc.
Neurology · 163d
Cleared Dec 18, 1998
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
K982712 · CAC
Genzyme Surgical Product (Genzyme...
Anesthesiology · 136d
Cleared Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · LOJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 109d