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
126553–126576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1990
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
K900117 · EJH
D.C. Dental Specialties
Dental · 83d
Cleared Apr 02, 1990
LINGUAL SHEATH
K900184 · EJF
Ormco Corp.
Dental · 76d
Cleared Apr 02, 1990
GOLD CIRCLE COIN
K900357 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
SAXON WET LUBE
K900358 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
EMBRACE
K900359 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
SAXON ULTRA THIN
K900360 · HIS
Safetex Corp.
Obstetrics & Gynecology · 67d
Cleared Apr 02, 1990
RADIOGRAPHIC INTENSIFYING SCREEN
K901014 · EAM
Infab Corp.
Radiology · 28d
Cleared Apr 02, 1990
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
K901075 · DBF
London Diagnostics, Inc.
Immunology · 25d
Cleared Apr 02, 1990
BETA-2 MICROGLOBULIN EIA
K901333 · JZG
Serex, Inc.
Immunology · 13d
Cleared Mar 30, 1990
MANUAL RESUSCITATOR
K895589 · BTM
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 196d
Cleared Mar 30, 1990
SUCTION CATHETER STRAIGHT/COUDE
K896730 · BSY
Unoplast A/S
Anesthesiology · 120d
Cleared Mar 30, 1990
OXYGEN CATHETERS
K896731 · BZB
Unoplast A/S
Anesthesiology · 120d
Cleared Mar 30, 1990
COULTER JT3
K896873 · GKZ
Coulter Corp.
Hematology · 112d
Cleared Mar 30, 1990
ATRIUM 2000, CHEST DRAIN
K897125 · KDQ
Atrium Medical Corp.
General Hospital · 94d
Cleared Mar 30, 1990
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133 · CBT
Transidyne General Corp.
Anesthesiology · 93d
Cleared Mar 30, 1990
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · JFL
Beckman Instruments, Inc.
Chemistry · 92d
Cleared Mar 30, 1990
ROCHE REAGENT FOR LDH
K900121 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 30, 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · DJG
Hycor Biomedical, Inc.
Toxicology · 77d
Cleared Mar 30, 1990
DELFIA TBG KIT
K900240 · CEE
Pharmacia, Inc.
Chemistry · 72d
Cleared Mar 30, 1990
CANNULA, SUCTION UTERINE
K900641 · HHI
Williams Specialty Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 30, 1990
ENZYMUN TEST(R) PROLACTIN
K900695 · CFT
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Mar 30, 1990
ITEM #273 CONTACT LENS CASES
K900777 · LRX
Magnivision, Inc.
Ophthalmic · 38d
Cleared Mar 30, 1990
ITEM #272 MAGNIF-EYES CONTACT LENS CASE
K900778 · LRX
Magnivision, Inc.
Ophthalmic · 38d
Cleared Mar 30, 1990
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · KLT
Boehringer Mannheim Corp.
Chemistry · 21d