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
146521–146544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
K853931 · JJY
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · DIF
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 03, 1985
BETA SCAN TRENDS METER
K851822 · CGA
Orange Medical Instruments, Inc.
Chemistry · 160d
Cleared Oct 03, 1985
PHASE II B-12/FOLATE KIT
K853224 · CDD
Medical & Scientific Designs, Inc.
Chemistry · 63d
Cleared Oct 03, 1985
PREGNA/TEST
K853269 · LCX
Modern Diagnostics, Inc.
Chemistry · 59d
Cleared Oct 03, 1985
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC
K853853 · JGJ
Technicon Instruments Corp.
Chemistry · 17d
Cleared Oct 02, 1985
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K851517 · DSI
Circadian, Inc.
Cardiovascular · 170d
Cleared Oct 02, 1985
PARA CON TM
K853715 · LKS
Para Scientific Co.
Microbiology · 28d
Cleared Oct 02, 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
K853717 · JLW
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 02, 1985
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · KPR
Victoreen, Inc.
Radiology · 23d
Cleared Oct 01, 1985
SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS
K843821 · CAC
Solco Basle, Inc.
Anesthesiology · 368d
Cleared Oct 01, 1985
EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN
K844776 · CCW
Medical Instruments and Lamps
Anesthesiology · 295d
Cleared Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · CFH
Helena Laboratories
Chemistry · 118d
Cleared Oct 01, 1985
LASERSAFE PERSONNEL AND PATIENT SHIELDS
K852405 · CAI
Lasersafe, Inc.
Anesthesiology · 117d
Cleared Oct 01, 1985
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A
K852708 · DTB
Telectronics, Inc.
Cardiovascular · 97d
Cleared Oct 01, 1985
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
K853171 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 63d
Cleared Oct 01, 1985
BETA-HCG MICROTITER PREGNANCY TEST
K853258 · JHI
Modern Diagnostics, Inc.
Chemistry · 60d
Cleared Oct 01, 1985
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
K853345 · BWC
31st. Centruy Medical Corp.
Anesthesiology · 50d
Cleared Oct 01, 1985
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
K853391 · JJE
Eiken Chemical Co., Inc.
Chemistry · 49d
Cleared Oct 01, 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Oct 01, 1985
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K853502 · BTR
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Oct 01, 1985
FLOURESCENT T12 UVA TANNING LAMP
K853545 · FTC
Light Sources, Inc.
General & Plastic Surgery · 36d
Cleared Oct 01, 1985
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C
K853587 · FTC
Uvatan Industries , Ltd.
General & Plastic Surgery · 34d
Cleared Oct 01, 1985
SUNJET MODELS 240/280
K853679 · FTC
Sunjet Manufacturer, Inc.
General & Plastic Surgery · 27d