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
110497–110520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
K935601 · FPA
Puritas Health Care, Inc.
General Hospital · 63d
Cleared Jan 21, 1994
IONOSIT BASE LINER
K935689 · EBD
Foremost Dental Mfg., Co.
Dental · 53d
Cleared Jan 21, 1994
CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K935714 · DYH
Confi-Dental Products Co.
Dental · 52d
Cleared Jan 21, 1994
P&FS PIT AND FISSURE SEALANT
K935727 · EBC
Jedental Co., Inc.
Dental · 51d
Cleared Jan 18, 1994
APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
K923299 · KMF
Aplicare, Inc.
General & Plastic Surgery · 561d
Cleared Jan 18, 1994
ALRAND INC. (DENTAL HAND INSTRUMENTS)
K926190 · EJP
Alrand, Inc.
Dental · 405d
Cleared Jan 18, 1994
SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
K931298 · LNH
General Electric Co.
Radiology · 309d
Cleared Jan 18, 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507 · EJK
Centrix, Inc.
Dental · 187d
Cleared Jan 18, 1994
LEADWIRE
K933603 · DSA
Sentry Medical Products, Inc.
Cardiovascular · 175d
Cleared Jan 18, 1994
REGENCY PLUS BRACKET
K933758 · EJF
Mid-American Dental Specialties, Inc.
Dental · 168d
Cleared Jan 18, 1994
EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO
K934019 · EBI
St. George Technology, Inc.
Dental · 154d
Cleared Jan 18, 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 131d
Cleared Jan 18, 1994
ANGIOSCOPE
K934696 · LYK
Intramed Laboratories, Inc.
Cardiovascular · 110d
Cleared Jan 18, 1994
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
K935018 · JIX
Alko Diagnostic Corp.
Chemistry · 90d
Cleared Jan 18, 1994
SCIMED ENTRE II PTCA GUIDE WIRE MODIFICATION
K935022 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Jan 18, 1994
ZENITH TOTAL ETCH 10% PHOSPHORIC ACID
K935032 · EBF
Foremost Dental Mfg., Inc.
Dental · 90d
Cleared Jan 18, 1994
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K935203 · MGQ
Renaissance Medical, Inc.
General & Plastic Surgery · 84d
Cleared Jan 18, 1994
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
K935547 · JIX
Alko Diagnostic Corp.
Chemistry · 62d
Cleared Jan 18, 1994
MEDSIM 300 PATIENT SIMULATOR
K935817 · DRT
Dynatech/Nevada, Inc.
Cardiovascular · 47d
Cleared Jan 14, 1994
SPLITTABLE SHEATH INTRODUCER SET
K920634 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 702d
Cleared Jan 14, 1994
RI-MED
K925297 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 450d
Cleared Jan 14, 1994
MPC-80 TRANSDUCER
K925978 · FIB
Molded Products, Inc.
Gastroenterology & Urology · 415d
Cleared Jan 14, 1994
SOLUTION SET WITH .2 MICRON FILTER
K930854 · FPA
Douglas Medical Products Corp.
General Hospital · 330d
Cleared Jan 14, 1994
COAXIAL ACUTE CATHETER
K931120 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 316d