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
84385–84408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1999
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
K984415 · KOJ
S.S. White Technologies, Inc.
Dental · 293d
Cleared Sep 29, 1999
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K991540 · LIT
AngioDynamics, Inc.
Cardiovascular · 149d
Cleared Sep 29, 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · DZE
Implant Innovations, Inc.
Dental · 112d
Cleared Sep 29, 1999
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · JOW
The Kendall Company, L.P.
Cardiovascular · 100d
Cleared Sep 29, 1999
OLYMPUS WORKING ELEMENT FOR PROBES
K992141 · FDC
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 97d
Cleared Sep 29, 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352 · LMD
Inteleradiology, Inc.
Radiology · 77d
Cleared Sep 29, 1999
DIAGNOSTIC ULTRASOUND, MODEL 1.0
K992378 · IYO
Volumetrics Medical Imaging, Inc.
Radiology · 75d
Cleared Sep 29, 1999
INTRAMAX ITI GUIDE CATHETER
K992622 · DQY
Intratherapeutics, Inc.
Cardiovascular · 55d
Cleared Sep 29, 1999
SPRING POWERLITE 2000
K992728 · EBZ
Spring Health Products, Inc.
Dental · 47d
Cleared Sep 29, 1999
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · HIB
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 47d
Cleared Sep 29, 1999
CARTO EP NAVIGATION SYSTEM
K992968 · DQK
Biosense Webster, Inc.
Cardiovascular · 26d
Cleared Sep 28, 1999
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE...
K990500 · EZL
The Kendal Co.
Gastroenterology & Urology · 223d
Cleared Sep 28, 1999
ORTHOPANTOMOGRAPH OP100D
K992385 · MUH
Instrumentarium Corp.
Radiology · 74d
Cleared Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · CEW
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P,...
K992798 · CDO
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P,...
K992800 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS...
K992801 · CIT
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
ENDOSTEPPER 1
K993188 · EKX
Phytron- Elektronik GmbH
Dental · 5d
Cleared Sep 27, 1999
BROADLINE OR TOWELS
K991667 · KKX
Broadline Medical Industries
General Hospital · 136d
Cleared Sep 27, 1999
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
K992117 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 96d
Cleared Sep 27, 1999
MODIFICATION OF PASCO MIC AND MIC/ID PANELS
K992420 · JTN
Pasco Laboratories, Inc.
Microbiology · 68d
Cleared Sep 27, 1999
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
K992558 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Sep 27, 1999
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 38d
Cleared Sep 24, 1999
SILVERLON WOUND PACKING STRIPS
K984210 · FRO
Argentum International, LLC
General & Plastic Surgery · 304d