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
165337–165360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1980
MISTY NEBULIZER
K802477 · CAF
Airlife, Inc.
Anesthesiology · 26d
Cleared Oct 31, 1980
SURGICAL KNIVES & PROBES
K802479 · HXB
Eder Instrument Co, Inc.
Orthopedic · 24d
Cleared Oct 31, 1980
7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
K802481 · DYG
Waters Assoc., Inc.
Cardiovascular · 24d
Cleared Oct 31, 1980
KEOFEED (R) EASY-FILL ENTERIC FEED BAG
K802482 · KNT
Health Development Corp.
Gastroenterology & Urology · 24d
Cleared Oct 31, 1980
MICRO-SUGICAL POWER INSTRUMENT SYSTEM
K802503 · EQJ
Spire Medical, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 31, 1980
FOLEY CATHETER
K802516 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 31, 1980
BASIN PACK
K802538 · FNY
Texas Medical Products, Inc.
General Hospital · 16d
Cleared Oct 31, 1980
COTTRELL 90/90 BACKTRAC
K802555 · HST
Lossing Orthopedic, Inc.
Neurology · 15d
Cleared Oct 31, 1980
SURCAN KNEE HOLDING DEVICE
K802558 · FWZ
Bend Orthopedic & Fracture Clinic
General & Plastic Surgery · 15d
Cleared Oct 31, 1980
HI VOLUME PUMPING CHAMBER
K802561 · JTB
Acacia, Inc.
Microbiology · 15d
Cleared Oct 31, 1980
TRANSETTE SYSTEM/COLLECTION & TRANSP
K802563 · JTW
Inolex Corp./Div of Biomedical
Microbiology · 15d
Cleared Oct 31, 1980
3MP-7 SCANNER RESPIRATORY MONITOR
K802565 · CAP
Bird Products Corp.
Anesthesiology · 14d
Cleared Oct 31, 1980
BETA LACTAMASE REAGENT DISK
K802566 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 14d
Cleared Oct 31, 1980
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
K802585 · KNT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 11d
Cleared Oct 31, 1980
ARTHROSCOPIC FAT PAD RETRACTOR
K802599 · GAD
The Anspach Effort, Inc.
General & Plastic Surgery · 10d
Cleared Oct 31, 1980
LEG BAG EXTENSION TUBE
K802606 · KNX
Associated Medical Products Co.
Gastroenterology & Urology · 10d
Cleared Oct 31, 1980
EMIT-STM OPIATE ASSAY
K802615 · DJE
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM BENZODIAZEPINE ASSAY
K802616 · JXM
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM BARBITURATE ASSAY
K802617 · DIS
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
K802618 · DKC
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
DRUG DETECTION SYSTEM
K802619 · JJQ
Syva Co.
Chemistry · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR
K802620 · DNN
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL ASSAY
K802621 · DMT
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
STERI-SLEEVE
K802629 · DQO
Cordis Corp.
Cardiovascular · 8d