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
170161–170184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 07, 1978
UTERINE SOUND, BURNETT DISPOSABLE
K781766 · HHM
C.R. Bard, Inc.
Obstetrics & Gynecology · 52d
Cleared Dec 07, 1978
INSTRUMENT CURNETT MINI-CONER BIOPSY
K781767 · KOH
C.R. Bard, Inc.
Obstetrics & Gynecology · 52d
Cleared Dec 07, 1978
CATHETER, EXTERNAL MALE NURSING CARE
K781780 · KNX
Medi-Tech, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 07, 1978
I.V. SET WITH IN-LINE FILTER
K781785 · FPA
Cutler Laboratories, Inc.
General Hospital · 50d
Cleared Dec 07, 1978
BEDDING, DISPOSABLE HOSPITAL
K781796 · KME
Kimberly-Clark Corp.
General Hospital · 43d
Cleared Dec 07, 1978
GRIP, HOSPITAL UTILITY
K781800 · KMK
Baka Manufacturing Co., Inc.
General Hospital · 45d