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
143353–143376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1986
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
K862375 · DSI
Grandcor Medical Systems
Cardiovascular · 7d
Cleared Jul 01, 1986
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
K862415 · IWZ
Parexel Intl. Corp.
Radiology · 6d
Cleared Jul 01, 1986
FTI 100 MEDICAL THERMAL IMAGER
K862416 · LMC
Parexel Intl. Corp.
Radiology · 6d
Cleared Jun 30, 1986
ARTIS ULTRASOUND IMAGING SYSTEM
K853565 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 308d
Cleared Jun 30, 1986
CARDIOSCAN DOPPLER OPTION
K860579 · JOP
Interspec, Inc.
Cardiovascular · 132d
Cleared Jun 30, 1986
INTELLIJECT INFUSION PUMP
K861207 · FRN
Intelligent Medicine, Inc.
General Hospital · 91d
Cleared Jun 30, 1986
INTELLIJECT MEDICATION SYRINGE
K861208 · FRN
Intelligent Medicine, Inc.
General Hospital · 91d
Cleared Jun 30, 1986
STORZ COMPUSCAN 68K
K861335 · IYO
Storz Instrument Co.
Radiology · 82d
Cleared Jun 30, 1986
META - HEALTH MODEL MTG III
K861771 · FLL
Meta Health, Inc.
General Hospital · 54d
Cleared Jun 30, 1986
HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
K862020 · BYD
Intertech/Ohio
Anesthesiology · 33d
Cleared Jun 30, 1986
ENZYMUN TEST TBG
K862109 · CEE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Jun 30, 1986
RAPID BACTERIURIA SCREEN (RBS)
K862195 · JXA
New Horizons Diagnostics Co.
Microbiology · 21d
Cleared Jun 30, 1986
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
K862216 · LGD
Labsystems, Inc.
Microbiology · 20d
Cleared Jun 27, 1986
LYOFOAM WOUND DRESSINGS
K860085 · NAD
Acme United Corp.
General & Plastic Surgery · 169d
Cleared Jun 27, 1986
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K860664 · CIC
Amresco, Inc.
Chemistry · 123d
Cleared Jun 27, 1986
SUCROSEP HUMAN PROLACTIN (HPR) IRMA
K861271 · CFT
Boots-Celltech Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 27, 1986
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K861361 · CHP
Serono Diagnostics, Inc.
Chemistry · 78d
Cleared Jun 27, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387 · JHS
Eastman Kodak Company
Chemistry · 74d
Cleared Jun 27, 1986
TB SERIES BIPOLAR PACING LEADS
K861403 · LDF
Oscor Medical Corp.
Cardiovascular · 73d
Cleared Jun 27, 1986
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
K861580 · JQW
Cetus Corp.
Chemistry · 60d
Cleared Jun 27, 1986
TRIGLYCERIDES GPO-TRINDER
K861635 · CDT
Catachem, Inc.
Chemistry · 59d
Cleared Jun 27, 1986
OSTEONICS ELBOW PROSTHESIS
K861680 · JDC
Osteonics Corp.
Orthopedic · 57d
Cleared Jun 27, 1986
TWIN BUN/GLUCOSE
K861775 · CDW
Boehringer Mannheim Corp.
Chemistry · 50d
Cleared Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · CDT
Boehringer Mannheim Corp.
Chemistry · 49d