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
102049–102072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1995
CLASS D LINEAR WITH ACTIVE TONE CONTROL
K952451 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
K952452 · ESD
Argosy Electronics
Ear, Nose, Throat · 42d
Cleared Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · JJS
Nova Biomedical Corp.
Chemistry · 37d
Cleared Jul 06, 1995
THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.
K952537 · LJT
Therex Corp.
General Hospital · 36d
Cleared Jul 06, 1995
QUICKIE TSR
K952641 · IOR
Sunrise Medical, Inc.
Physical Medicine · 27d
Cleared Jul 06, 1995
MED-TRON SPECT IMAGING TABLE
K952701 · IZZ
Med-Tron Products, Inc.
Radiology · 23d
Cleared Jul 05, 1995
ORTHOPEDIC SCREW FIXATION
K932350 · HWC
Osteomed Corp.
Orthopedic · 782d
Cleared Jul 05, 1995
ORTHOPEDIC BONE PLATE
K932352 · HRS
Osteomed Corp.
Orthopedic · 782d
Cleared Jul 05, 1995
LINK ENDO MODEL REVISION CUP
K943986 · HRS
Turnkey Intergration USA, Inc.
Orthopedic · 323d
Cleared Jul 05, 1995
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K951533 · KDH
Ballard Medical Products
Gastroenterology & Urology · 93d
Cleared Jul 05, 1995
LOCK-UP
K951736 · FMI
Medline
General Hospital · 83d
Cleared Jul 05, 1995
UBI MAGIWEL FERRITIN QUANTITATIVE
K951993 · DBF
United Biotech, Inc.
Immunology · 68d
Cleared Jul 05, 1995
BIPOLAR COAGULATION INSTRUMENT
K952161 · GEI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 58d
Cleared Jul 05, 1995
OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES
K952182 · GKZ
Immunotech, Inc.
Hematology · 57d
Cleared Jul 05, 1995
HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM...
K952261 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 51d
Cleared Jul 05, 1995
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · LYY
Cypress Medical Products, Ltd.
General Hospital · 55d
Cleared Jul 05, 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425 · JHN
Olympus America, Inc.
Immunology · 42d
Cleared Jul 05, 1995
SYMBIOSIS BIPOLAR FORCEPS
K952432 · GEI
Symbiosis Corp.
General & Plastic Surgery · 42d
Cleared Jul 03, 1995
PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR
K932922 · MED
Cottrell, Ltd.
General Hospital · 748d
Cleared Jul 03, 1995
BICORE SMARTCATH INTRATRACHEAL CATHETER
K935788 · MOD
Bicore Monitoring Systems
Anesthesiology · 574d
Cleared Jul 03, 1995
HARPOON SUTURE ANCHORS
K943806 · HWC
Biomet, Inc.
Orthopedic · 333d
Cleared Jul 03, 1995
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
K945985 · DQK
Burdick, Inc.
Cardiovascular · 207d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488 · DRX
Graphic Controls Corp.
Cardiovascular · 147d
Cleared Jul 03, 1995
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
K950489 · DRX
Graphic Controls Corp.
Cardiovascular · 147d