Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
171001–171024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1978
RESPIRATOR, BANTAM MODEL
K781161 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 159d
Cleared Dec 11, 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327 · DTE
Intermedics, Inc.
Cardiovascular · 132d
Cleared Dec 11, 1978
TRAY, ARTERIAL BLOOD GAS SAMPLING
K781857 · CBT
Jelco Laboratories
Anesthesiology · 35d
Cleared Dec 08, 1978
OMNI STIK
K781616 · CBT
Unitron Corp.
Anesthesiology · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS SA, 350, SAM 500
K781619 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS, MDM 1060, MDM 1090
K781620 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODELS, MAM 1260 MAM 1290
K781621 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER MODEL ACS 16
K781622 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING MODELS MUM 860, MUM 890
K781623 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD MODEL MVM 860, MVM 890
K781625 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER, ACV 14, ACV 23
K781626 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 08, 1978
PACING LEAD ADAPTER MODEL ADB 21
K781627 · DTD
R.E. Brown Co., Inc.
Cardiovascular · 79d
Cleared Dec 07, 1978
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC
K780960 · DIF
Vitek Systems, Inc.
Toxicology · 178d
Cleared Dec 07, 1978
THEOPHYLLINE CONTROL SERUM
K780961 · LAS
Vitek Systems, Inc.
Toxicology · 178d
Cleared Dec 07, 1978
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405 · FKP
Union Carbide Corp.
Gastroenterology & Urology · 115d
Cleared Dec 07, 1978
SIEMENS ULTRATHERM 708
K781455 · IMJ
Elmed, Inc.
Radiology · 106d
Cleared Dec 07, 1978
TOXELISA TEST KIT
K781549 · GLZ
Microbiological Assoc.
Microbiology · 86d
Cleared Dec 07, 1978
NERVE LOCATER/STIMULATOR
K781569 · ETN
Intermedics, Inc.
Ear, Nose, Throat · 84d
Cleared Dec 07, 1978
ULTRAFILTRATION SCALE
K781633 · FIL
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 77d
Cleared Dec 07, 1978
SURGITEK DOUBLE J URETEROL STENT
K781641 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 77d
Cleared Dec 07, 1978
ULTRASONIC TRANSDUCERS
K781649 · ITX
Echo Laboratories, Inc.
Radiology · 72d
Cleared Dec 07, 1978
COLLAGENREAGENT HORM
K781693 · JOZ
Hormon-Chemie Munchem Gmch
Hematology · 64d
Cleared Dec 07, 1978
PACEMAKER, MODEL 229-01
K781738 · DXY
Intermedics, Inc.
Cardiovascular · 51d
Cleared Dec 07, 1978
IV SET WITH GRADUATED CHAMBER
K781744 · FPA
National Patent Development Corp.
General Hospital · 48d