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
171385–171408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1978
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526 · GMD
I M, Inc.
Microbiology · 28d
Cleared Apr 28, 1978
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · DQK
Bd Becton Dickinson Vacutainer...
Cardiovascular · 24d
Cleared Apr 28, 1978
AORTIC PUMP
K780567 · DWS
Ethicon, Inc.
Cardiovascular · 22d
Cleared Apr 28, 1978
UNISTAT OXIMETER
K780625 · DQA
American Optical Corp.
Anesthesiology · 14d
Cleared Apr 28, 1978
DRY SILVER PROCESSOR MODEL 1226
K780640 · DSF
Honeywell, Inc.
Cardiovascular · 11d
Cleared Apr 28, 1978
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · CDX
Nuclear Diagnostics, Inc.
Toxicology · 11d
Cleared Apr 28, 1978
AIR-PWOERED COLDRILL
K780646 · EKX
Medishield, Inc.
Dental · 11d
Cleared Apr 28, 1978
HEARING AID, EARETTE
K780654 · ESD
Oticon Corp.
Ear, Nose, Throat · 9d
Cleared Apr 28, 1978
IMPRESSION TRAY
K780678 · EHY
Rocky Mountain Orthodontics, Inc.
Dental · 4d
Cleared Apr 27, 1978
TOTAL KNEE SYSTEM
K780299 · HRY
Richard'S Medical Equip., Inc.
Orthopedic · 64d
Cleared Apr 27, 1978
COLOPLAST-DURASEAL OSTOMY APPLIANCE
K780409 · EZS
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 27, 1978
BODY WARMER
K780426 · IMD
Q-Matic Corp.
Physical Medicine · 41d
Cleared Apr 27, 1978
H.P. MEDICAL GRADE SILICONE TUBING
K780470 · KDL
Dow Corning Corp. Healthcare...
Gastroenterology & Urology · 36d
Cleared Apr 27, 1978
HUMIDIFIER FILTER
K780535 · CAH
Hudson Oxygen Therapy Sales Co.
General Hospital · 24d
Cleared Apr 27, 1978
AQUAPAK PREFILLED HUMIDIFIER
K780562 · BTT
Respiratory Care, Inc.
Anesthesiology · 20d
Cleared Apr 27, 1978
TEMPERATURE INDICATOR
K780580 · KPD
Respiratory Care, Inc.
General Hospital · 17d
Cleared Apr 27, 1978
SHADOW-CATHS
K780643 · FJS
Quinton, Inc.
Gastroenterology & Urology · 10d
Cleared Apr 27, 1978
DAYSTAR SELECTRA & SELECTRA/ORBITER
K780666 · FSY
Castle Co.
General & Plastic Surgery · 48d
Cleared Apr 24, 1978
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · KSF
Bd Becton Dickinson Vacutainer...
Hematology · 95d
Cleared Apr 24, 1978
NORMAL UNASSAYED CONTROL SERA
K780351 · JJY
Macomb Chemical Co.
Hematology · 52d
Cleared Apr 24, 1978
THYRO-ZYME-T4 ASSAY KIT
K780401 · CDX
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Apr 24, 1978
LOW IIONIC STRENGTH SOLUTION
K780413 · KSG
Pfizer, Inc.
Hematology · 40d
Cleared Apr 24, 1978
SGOT/AST REAGENT SYSTEM
K780443 · CIT
American Monitor Corp.
Chemistry · 35d
Cleared Apr 24, 1978
EMIT CARBAMAZEPINE ASSAY
K780466 · KLT
Syva Co.
Toxicology · 33d