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
145081–145104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · CDT
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Feb 19, 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199 · JIX
American Dade
Chemistry · 54d
Cleared Feb 19, 1986
REFLECTIVE BLANKET
K860066 · KME
O.R. Concepts, Inc.
General Hospital · 44d
Cleared Feb 19, 1986
URIC ACID REAGENT SET
K860111 · LFQ
Technostics Intl.
Chemistry · 37d
Cleared Feb 19, 1986
NURSERY AMBIENT LIGHT METER
K860120 · FMS
Rocky Mountain Medical Corp.
General Hospital · 37d
Cleared Feb 19, 1986
TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT
K860130 · CDZ
Cambridge Medical Technology
Chemistry · 36d
Cleared Feb 19, 1986
UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
K860168
Universal Medical Instrument Corp.
General & Plastic Surgery · 33d
Cleared Feb 19, 1986
PHAKOSYSTEMS CT-100 CAUTERY MODULE
K860236 · GEI
Phakosystems, Inc.
General & Plastic Surgery · 27d
Cleared Feb 19, 1986
100% COTTON ABSORBENT TOWEL
K860248 · KKX
Devon Industries, Inc.
General Hospital · 26d
Cleared Feb 19, 1986
REESE ARTHRODESIS SCREW
K860323 · HWC
Osteotomy Guide Co.
Orthopedic · 21d
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · CIX
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 19, 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · KKX
Standard Textile Co., Inc.
General Hospital · 15d
Cleared Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · JJX
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 19, 1986
NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE
K860492 · FRN
Nordisk Infuser System
General Hospital · 16d
Cleared Feb 19, 1986
RELIANCE MODEL 200 PODIATRY CHAIR
K860519 · LGX
F. & F. Koenigkramer
General Hospital · 8d
Cleared Feb 18, 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861 · DXT
Medical Components, Inc.
Cardiovascular · 354d
Cleared Feb 18, 1986
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · MBV
Protek, Inc.
Orthopedic · 165d
Cleared Feb 18, 1986
MONOPOLAR INJECTION NEEDLE ELECTRODE
K854793 · HLW
Oculinum, Inc.
Ophthalmic · 75d
Cleared Feb 18, 1986
OMKNEE SYSTEM
K854883 · JWH
Orthomet, Inc.
Orthopedic · 74d
Cleared Feb 18, 1986
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · DQX
Dlp, Inc.
Cardiovascular · 60d
Cleared Feb 18, 1986
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
K855095 · LLO
Surgical Laser Technologies, Inc.
Anesthesiology · 57d
Cleared Feb 18, 1986
CIRIBART GYUDUBG CATGETER
K855103 · DQO
Mansfield Scientific, Inc.
Cardiovascular · 57d
Cleared Feb 18, 1986
THARIES FIBER
K855148
Zimmer, Inc.
Orthopedic · 54d
Cleared Feb 18, 1986
MAGNESIUM REAGENT SET
K855190 · JGJ
Technostics Intl.
Chemistry · 54d