FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87697–87720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1998
FUJINON EVL-F VIDEO LAPROSCOPE
K983561 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 64d
Cleared Dec 16, 1998
HYSTEROSCOPIC GIFT CATHETER SETS
K983587 · MQF
Cook Ob/Gyn
Obstetrics & Gynecology · 64d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K983605 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
K983606 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
COOK TEST TUBE HEATER
K983609 · MQG
Cook Ob/Gyn
Obstetrics & Gynecology · 63d
Cleared Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
K983672 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Dec 16, 1998
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
K983807 · JJY
Bio-Rad
Immunology · 49d
Cleared Dec 16, 1998
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE...
K983876 · EBI
Mycone Dental Supply Co., Inc. (A/K/A...
Dental · 44d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Dec 16, 1998
QUADRANT POSTERIOR DENSE
K984044 · EBF
Cavex Holland BV
Dental · 33d
Cleared Dec 16, 1998
MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY
K984185 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 23d
Cleared Dec 16, 1998
OSTEO 9MM IC TIBIAL NAIL
K984353 · HSB
Osteonics Corp.
Orthopedic · 9d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Dec 15, 1998
ELECTRON WEDGE MODEL MT-EW-1000
K981992 · IXI
Med-Tec,Inc.
Radiology · 190d
Cleared Dec 15, 1998
ADVANTAGE WINDOWS (AW) FUSION
K983256 · LLZ
GE Medical Systems
Radiology · 90d
Cleared Dec 15, 1998
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
K983392 · LLZ
Data Ray
Radiology · 81d
Cleared Dec 15, 1998
FRAMEWAVE WEB
K983401 · LLZ
Ml Strategies, Inc.
Radiology · 78d
Cleared Dec 15, 1998
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER...
K983498 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
K983601 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 62d
Cleared Dec 15, 1998
DISTAFLO BYPASS GRAFT
K983769 · DYF
Impra, Inc.
Cardiovascular · 50d
Cleared Dec 15, 1998
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
K984318 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
K984323 · JJX
Bio-Rad
Chemistry · 12d