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
105913–105936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1994
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL
K943422 · DIF
Utak Lab, Inc.
Toxicology · 110d
Cleared Nov 02, 1994
INFORMER PLUS
K943481 · KMI
Micro-Tech Medical, Inc.
General Hospital · 106d
Cleared Nov 02, 1994
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · CFT
Biomerieux Vitek, Inc.
Chemistry · 89d
Cleared Nov 02, 1994
STAT PAK
K943820 · EKJ
Magnum Instruments, Inc.
Dental · 89d
Cleared Nov 02, 1994
TRUZONE PFM DISPOSABLE MOUTHPIECE
K944512 · BYP
Monaghan Medical Corp.
Anesthesiology · 48d
Cleared Nov 02, 1994
FLUIDS PACK
K944516 · JIT
Alko Diagnostic Corp.
Chemistry · 48d
Cleared Nov 02, 1994
BODY FLUIDS BARRIER KIT
K944545 · FXX
Ani Safety, Inc.
General Hospital · 47d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562 · LDJ
Microgenics Corp.
Chemistry · 64d
Cleared Nov 02, 1994
V-DELTA N (V-DELTA LOY), AUROFLUID 2PF
K944572 · EJT
Metalor
Dental · 44d
Cleared Nov 02, 1994
KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES
K944796 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 35d
Cleared Nov 02, 1994
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES
K944823 · GEI
Karl Storz Endoskop GmbH
General & Plastic Surgery · 34d
Cleared Nov 02, 1994
JARIT ENDOSCOPES, MODELS 600-600
K944870 · GCJ
J. Jamner Surgical Instruments, Inc.
General & Plastic Surgery · 41d
Cleared Nov 02, 1994
URINE COLLECTOR & ACCESSORIES
K945204 · FAQ
Nelmed Corp.
Gastroenterology & Urology · 8d
Cleared Nov 01, 1994
THERMABOND V
K926378 · EJT
Dentecon, Inc.
Dental · 679d
Cleared Nov 01, 1994
BODY FAT ANALYZER MODEL TBF-105
K930599 · DSB
Tanita Corp. of America
Cardiovascular · 634d
Cleared Nov 01, 1994
MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM
K933057 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 497d
Cleared Nov 01, 1994
OXLIFE OXYGEN CONCENTRATOR
K933081 · CAW
Oxlife, Inc.
Anesthesiology · 496d
Cleared Nov 01, 1994
K3 SYSTEM
K934644 · DRT
Astro-Med, Inc.
Cardiovascular · 398d
Cleared Nov 01, 1994
BENNETT X-RAY DIGITAL SPOT IMAGER
K935428 · IZH
Bennett X-Ray Technologies
Radiology · 356d
Cleared Nov 01, 1994
ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES
K935429 · DRX
Arbo Medical, Inc.
Cardiovascular · 356d
Cleared Nov 01, 1994
REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
K940467 · DTE
Remington Medical, Inc.
Cardiovascular · 272d
Cleared Nov 01, 1994
PEAKLOG AND DISPLAY SOFTWARE
K940835 · BZH
Medtrac Technologies Corp.
Anesthesiology · 251d
Cleared Nov 01, 1994
PEAKLOG AND DISPLAY SOFTWARE
K940836 · BZH
Tamarac Systems Corp.
Anesthesiology · 251d
Cleared Nov 01, 1994
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K941750 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 207d