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
96145–96168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1996
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K963036 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 63d
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
K963286 · DAD
Beckman Instruments, Inc.
Immunology · 47d
Cleared Oct 07, 1996
TEAM ETCH
K963311 · EBF
Centrix, Inc.
Dental · 46d
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
K963427 · DDG
Beckman Instruments, Inc.
Immunology · 38d
Cleared Oct 07, 1996
DOUBLE SUPPORT PONCHO/SLIDER PONCHO
K963447 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
ECONO BELT
K963448 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
PELVIC HOLDER
K963449 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST
K963450 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE...
K963454 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
K963551 · JJX
Biocell Laboratories, Inc.
Chemistry · 32d
Cleared Oct 07, 1996
MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL...
K963583 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 31d
Cleared Oct 04, 1996
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · DXT
Contour Fabricators of Florida, Inc.
Cardiovascular · 295d
Cleared Oct 04, 1996
COMPAT NASOJEJUNAL FEEDING TUBE
K961664 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 157d
Cleared Oct 04, 1996
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961821 · GXY
Aspect Medical Systems, Inc.
Neurology · 147d
Cleared Oct 04, 1996
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · JOH
Mallinckrodt Medical
Anesthesiology · 121d
Cleared Oct 04, 1996
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
K962652 · KNX
Customed, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 04, 1996
SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
K962663 · MEB
Solopak Medical Products, Inc.
General Hospital · 88d
Cleared Oct 04, 1996
DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
K962676 · FGO
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 04, 1996
ECOGEL 300 TENS GEL
K962681 · GYB
Eco-Med Pharmaceuticals, Inc.
Neurology · 86d
Cleared Oct 04, 1996
EG-3400, VIDEO GASTROSCOPE
K962897 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 71d
Cleared Oct 04, 1996
SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
K963355 · MEB
Solopak Medical Products, Inc.
General Hospital · 39d
Cleared Oct 04, 1996
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
K963377 · HIB
North Eos Industries, Inc.
Obstetrics & Gynecology · 38d
Cleared Oct 03, 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · CAH
Mercury Medical
General Hospital · 372d
Cleared Oct 03, 1996
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · JZG
Behring Diagnostics, Inc.
Immunology · 300d