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
132385–132408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004 · GTJ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
CAPILLARY TUBE, BLOOD COLLECTION
K885138 · GIO
Coeur Laboratories, Inc.
Hematology · 54d
Cleared Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 47d
Cleared Feb 07, 1989
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
K885269 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 47d
Cleared Feb 07, 1989
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE
K885288 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0
K885289 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · LGD
Labsystems, Inc.
Microbiology · 26d
Cleared Feb 07, 1989
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
K890183 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
K890184 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER
K890279 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 26d
Cleared Feb 07, 1989
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · LIE
Difco Laboratories, Inc.
Microbiology · 15d
Cleared Feb 07, 1989
MODIFIED D-DI-TEST KIT
K890399 · GHH
American Bioproducts Co.
Hematology · 14d
Cleared Feb 06, 1989
GLOVE, SURGICAL
K884425 · KGO
Med-Pak Corp.
General Hospital · 109d
Cleared Feb 06, 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Feb 06, 1989
ARBO PINK H82P
K884775 · DRX
Arbo Medical, Inc.
Cardiovascular · 82d
Cleared Feb 06, 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · DSI
Del Mar Avionics
Cardiovascular · 76d
Cleared Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Feb 06, 1989
JEHLE CORONARY PERFUSION CATHETERS
K884946 · KRA
Pilling Co.
Cardiovascular · 70d
Cleared Feb 06, 1989
SUPREME TONING SYSTEMS
K885095 · BXB
Supreme Toning Systems
Physical Medicine · 59d
Cleared Feb 06, 1989
GRAFT GUARD
K885136 · LZM
Sorex Medical
General & Plastic Surgery · 53d
Cleared Feb 06, 1989
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · DWF
Quinton, Inc.
Cardiovascular · 61d
Cleared Feb 06, 1989
MODEL 8700 PULSE OXIMETER
K890033 · DQA
Nonin Medical, Inc.
Anesthesiology · 33d
Cleared Feb 06, 1989
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749
K890059 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 31d
Cleared Feb 06, 1989
A10 ULTRASCOPE RECORDER
K890142 · DSF
Ems Medical, Inc.
Cardiovascular · 24d