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
111529–111552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1993
OHMEDA MODEL 5330 ANESTHETIC MONITOR
K931439 · CBQ
Ohmeda Medical
Anesthesiology · 211d
Cleared Oct 19, 1993
DIOMED 25 25W SURGICAL DIODE LASER
K931776 · GEX
Dio-Med Corp.
General & Plastic Surgery · 193d
Cleared Oct 19, 1993
ENDOSCOPE
K933106 · ODF
Origin Medsystems, Inc.
Gastroenterology & Urology · 116d
Cleared Oct 19, 1993
BABISTICK
K933365 · FMK
Graphic Controls Corp.
General & Plastic Surgery · 102d
Cleared Oct 19, 1993
BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER
K934540 · CAH
Bird Life Design
General Hospital · 33d
Cleared Oct 18, 1993
WINDMERE PRELUDE III
K924237 · ISA
Windmere Corp.
Physical Medicine · 420d
Cleared Oct 18, 1993
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · DXO
Baxter Healthcare Corp
Cardiovascular · 343d
Cleared Oct 18, 1993
UNI II
K925756 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 339d
Cleared Oct 18, 1993
CARDIO2 CTCKE
K930253 · ISD
Ergometrx, Inc.
Physical Medicine · 272d
Cleared Oct 18, 1993
LD 400
K930937 · HPT
Vismed, Inc.
Ophthalmic · 237d
Cleared Oct 18, 1993
BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE
K931019 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 234d
Cleared Oct 18, 1993
OLYMPUS AMYLASE REAGENT
K931301 · CIJ
Olympus Corp.
Chemistry · 217d
Cleared Oct 18, 1993
BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE
K931464 · LYK
Baxter Healthcare Corp
Cardiovascular · 208d
Cleared Oct 18, 1993
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · GIZ
American Diagnostic Corp.
Hematology · 167d
Cleared Oct 18, 1993
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · JIX
Helena Laboratories
Chemistry · 132d
Cleared Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · CDX
Sigma Diagnostics, Inc.
Chemistry · 123d
Cleared Oct 18, 1993
FASHION ITALIANA EYEWEAR
K933089 · HQY
Fashion Italiana, Inc.
Ophthalmic · 117d
Cleared Oct 18, 1993
SIGMA CRE REAGENT
K933697 · CGX
Sigma Chemical Co.
Chemistry · 81d
Cleared Oct 18, 1993
MUGNIER JERIK SUNGLASSES
K933718 · HQY
Huntley Global Ent.
Ophthalmic · 80d
Cleared Oct 18, 1993
FRAME-SPECTACLE
K933765 · HQZ
Clearvision Optical Co., Inc.
Ophthalmic · 76d
Cleared Oct 18, 1993
OPTO LINE SRL
K933809 · HQZ
Optoline S.R.L.
Ophthalmic · 75d
Cleared Oct 18, 1993
FRAMES
K933865 · HQZ
Hillman'S, the Eyecare Co., Inc.
Ophthalmic · 70d
Cleared Oct 18, 1993
SPECTACLE FRAMES
K933891 · HQZ
Euro Frame Design, Inc.
Ophthalmic · 69d
Cleared Oct 18, 1993
ASICS SUNGLASSES
K933905 · HQY
Asics Tiger Corp.
Ophthalmic · 68d