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
161305–161328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1982
ASTRA-T CALCIUM REAGENT
K820090 · CIC
Hi Chem, Inc.
Chemistry · 15d
Cleared Jan 28, 1982
PATHWAY PH BLOOD GAS CONTROL
K820103 · JJS
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Jan 28, 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · BZO
3M Company
Anesthesiology · 10d
Cleared Jan 28, 1982
BABYBIRD 2 VENTILATOR
K820132 · CBK
3M Company
Anesthesiology · 10d
Cleared Jan 28, 1982
PRIMIDONE REAGENT TEST KIT
K820138 · DJD
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Jan 28, 1982
PHILLY INFANT BOLT
K820151 · GWN
Philadelphia Medical Specialties
Neurology · 9d
Cleared Jan 26, 1982
IL 703, STAT SEPARATOR
K812750 · JRL
Instrumentation Laboratory CO
Hematology · 119d
Cleared Jan 26, 1982
MODERN MATERIALS' INLAY CSTG. WAXES,A-C
K812804 · EGD
Modern Materials
Dental · 112d
Cleared Jan 26, 1982
HEPAQUANT
K813011 · JOX
Streck Laboratories, Inc.
Pathology · 91d
Cleared Jan 26, 1982
TOXOELISA TEST KIT
K813221 · LGD
M.A. Bioproducts
Microbiology · 78d
Cleared Jan 26, 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · KLK
Critikon Company, LLC
Anesthesiology · 60d
Cleared Jan 26, 1982
LINQUAL-ORAL TRAINING SPLINT
K813603
Charles F. Samelson, M.D.
Cardiovascular · 29d
Cleared Jan 26, 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · CGX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 26, 1982
AFT SYSTEM PROFICIENCY TESTING PROGRAM
K820088 · DBL
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Jan 25, 1982
IRRIGATION SYRINGE
K810185 · FQH
Karoco Intl.
General Hospital · 381d
Cleared Jan 25, 1982
TEGADERM TRANSPARENT DRESSING
K812678 · FRO
3M Company
General & Plastic Surgery · 125d
Cleared Jan 25, 1982
TRANSDUCER ANTISEPTIC TOWELETTE
K812776 · ITX
Echo Laboratories, Inc.
Radiology · 112d
Cleared Jan 25, 1982
SAGE 2200 STERILE SPECIMEN CONTAINER
K813408 · FMT
Sage Products, Inc.
Radiology · 49d
Cleared Jan 25, 1982
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K813642 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 26d
Cleared Jan 25, 1982
PBC SYRINGE
K813647 · FMF
Philadelphia Biologics Center
General Hospital · 25d
Cleared Jan 25, 1982
SPINOCAN SPINAL NEEDLE
K820047 · BSP
Burron Medical Products, Inc.
Anesthesiology · 17d
Cleared Jan 25, 1982
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 13d
Cleared Jan 25, 1982
ESKA JONAS SILICONE-SILVER PENILE PROST
K820081 · FAE
Dacomed Corp.
Gastroenterology & Urology · 13d
Cleared Jan 22, 1982
SPIROX H
K812956 · BZK
Cairco , Ltd.
Anesthesiology · 93d