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
136249–136272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1988
HCG-NOSTICK
K880328 · JHJ
Organon Teknika Corp.
Chemistry · 49d
Cleared Mar 15, 1988
TELOS DISTAL TARGETING DEVICE
K880381 · HXY
Austin Assoc.
Orthopedic · 48d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
K880395 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880396 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880397 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · JDI
Orthomet, Inc.
Orthopedic · 41d
Cleared Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495 · JJW
Bio-Rad
Chemistry · 40d
Cleared Mar 15, 1988
CONCEP-7-BHCG
K880577 · JHI
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Mar 15, 1988
TRIGLYCERIDES (GPO-TRINDER)
K880628 · CDT
Tech-Co, Inc.
Chemistry · 28d
Cleared Mar 15, 1988
EASY-TEST LACTIC ACID (LA)
K880787 · KHP
Diagnostic Systems
Chemistry · 18d
Cleared Mar 15, 1988
DYNATRON 2000
K880912 · IKE
Dynatronics Corp.
Physical Medicine · 12d
Cleared Mar 14, 1988
THE MICRO-VENT/HA
K873255 · DZE
Core-Vent Corp.
Dental · 210d
Cleared Mar 14, 1988
KTP/532 LASER FOR OB-GYN USE
K874837 · HHR
Laserscope
Obstetrics & Gynecology · 111d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007 · FST
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277 · LXB
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 14, 1988
SANITARY MENSTRUAL NAPKIN
K875309 · HHD
Universal Health Care Products...
Obstetrics & Gynecology · 76d
Cleared Mar 14, 1988
GYNESCOPE
K880195 · HEX
Medgyn Products, Inc.
Obstetrics & Gynecology · 48d
Cleared Mar 14, 1988
MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
K880223 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 54d
Cleared Mar 14, 1988
WIDEX HEARING AID MODEL C1
K880273 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 52d
Cleared Mar 14, 1988
SELF GUIDING (SG) INTERLOCKING NAIL
K880737 · HSB
Orthopaedic Designs, Inc.
Orthopedic · 19d
Cleared Mar 14, 1988
BUSHLINE CARE CHAIR
K880786 · INO
Bushline Corp.
Physical Medicine · 17d