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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164665–164688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1981
ADVANCEMED HOLTER RECORDERS
K803224 · DSH
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCEMED EXAMINER
K803225 · DSF
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
4-CHANNEL ECG TELEMETRY MON. SYST. #3045
K803229 · DRG
Cambridge Instruments, Inc.
Cardiovascular · 25d
Cleared Jan 13, 1981
TYGON TUBING
K803277 · DWE
Electromedics, Inc.
Cardiovascular · 15d
Cleared Jan 13, 1981
MATTRESS, AIR FLOATATION, ALTERN. PRESS.
K803307 · FNM
Intl. Medical Equipment Corp.
General Hospital · 14d
Cleared Jan 12, 1981
UTERINE CURETTE
K802313 · HCY
Gynemetrics, Inc.
Obstetrics & Gynecology · 111d
Cleared Jan 12, 1981
UTERINE SOUND
K802315 · HHM
Gynemetrics, Inc.
Obstetrics & Gynecology · 111d
Cleared Jan 12, 1981
KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610
K802457 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 96d
Cleared Jan 12, 1981
KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611
K802458 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 96d
Cleared Jan 12, 1981
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K802760 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 68d
Cleared Jan 12, 1981
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931 · GNX
Orion Diagnostica, Inc.
Microbiology · 54d
Cleared Jan 12, 1981
MEUROMETRICS MONITOR
K803233 · GWS
Dade Medical, Inc.
Neurology · 21d
Cleared Jan 12, 1981
MICROMEDIC REAGENT DISPENSER
K803252 · JTC
Micromedic Systems
Microbiology · 20d
Cleared Jan 12, 1981
MINI-TIP CULTURETTE
K803298 · JTW
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Jan 09, 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · CDD
Corning Medical & Scientific
Hematology · 119d
Cleared Jan 09, 1981
EMG-UT 30
K802390 · HCC
American Scientific Corp.
Neurology · 99d
Cleared Jan 09, 1981
EMG-UT 40
K802391 · HCC
American Scientific Corp.
Neurology · 99d
Cleared Jan 09, 1981
BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.
K802451 · JHQ
Syn-Kit, Inc.
Chemistry · 93d
Cleared Jan 09, 1981
LIQUID CRYSTAL THERM. 8 EVENT MONITOR
K802778 · KPD
Djinnii Industires, Inc.
General Hospital · 65d
Cleared Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · JHX
Beckman Instruments, Inc.
Chemistry · 60d
Cleared Jan 09, 1981
RAYTHEON MEDICAL IMAGING
K802888 · IXL
Machlett Laboratories, Inc.
Radiology · 53d
Cleared Jan 09, 1981
CYTOMEGALO VIRUS & CONTROLS
K802930 · GQH
Orion Diagnostica, Inc.
Microbiology · 51d
Cleared Jan 09, 1981
CINESCOPE III RADIOGRAPHIC GENERATOR
K802941 · IZO
Controtec, Inc.
Radiology · 51d
Cleared Jan 09, 1981
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K802953 · JAA
General Electric Co.
Radiology · 50d