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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81049–81072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
K000251 · MJC
Cook Urological, Inc.
Gastroenterology & Urology · 216d
Cleared Aug 30, 2000
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
K001052 · IYE
Med-Tec,Inc.
Radiology · 149d
Cleared Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
K001127 · MOB
The Binding Site, Ltd.
Immunology · 149d
Cleared Aug 30, 2000
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
K001300 · DWL
Confection Medicale D.R., Inc.
General Hospital · 128d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Aug 30, 2000
SLIDESCAN
K001420 · JOY
Applied Imaging Corp.
Hematology · 117d
Cleared Aug 30, 2000
UTERINE TENACLUM HOOK
K001818 · HDC
Towne Brothers (Pvt.), Ltd.
Obstetrics & Gynecology · 76d
Cleared Aug 30, 2000
NEUROVASCULAR ARRAY COIL
K001946 · MOS
Ge Medical Systems, Inc.
Radiology · 65d
Cleared Aug 30, 2000
JBC OPAQUE AND GLITTER
K002048 · EBI
J.B.C and Co.
Dental · 65d
Cleared Aug 30, 2000
TOTAL PSA MICROTITER ELISA
K002121 · LTJ
Oncogene Science, Inc.
Immunology · 48d
Cleared Aug 30, 2000
FORAMATRON V, MODEL D680
K002195 · LQY
Parkell, Inc.
Dental · 41d
Cleared Aug 30, 2000
PROTON VISION 7.0
K002312 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Aug 30, 2000
COMPLEXED PSA MICROTITER ELISA
K002313 · LTJ
Oncogene Science, Inc.
Immunology · 30d
Cleared Aug 30, 2000
PURILENS SALINE SOLUTION
K002319 · LPN
Purilens, Inc.
Ophthalmic · 30d
Cleared Aug 30, 2000
MODIFICATION OF ACL ADVANCE
K002400 · JPA
Instrumentation Laboratory CO
Hematology · 26d
Cleared Aug 30, 2000
MICRO-MAX, MODEL 319
K002404 · IXW
Tek Marketing, Inc.
Radiology · 23d
Cleared Aug 30, 2000
TCD 100M, PWD13 TRANSDUCER
K002533 · IYN
Spencer Technologies
Radiology · 14d
Cleared Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
K002536 · JJS
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
OBC-096 BREAST ARRAY COIL
K002539 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Aug 30, 2000
MINOLTA PULSOX-3/MINOLTA PULSOX-3I
K984570 · DQA
In-X Corp.
Anesthesiology · 616d
Cleared Aug 30, 2000
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · LNH
Medis Medical Imaging Systems BV
Radiology · 254d
Cleared Aug 29, 2000
AVID-NIT LOSS OF RESISTANCE SYRINGE
K001731 · FMF
Avid Medical, Inc.
General Hospital · 83d
Cleared Aug 29, 2000
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 68d