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
85057–85080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1999
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
K992186 · GEI
Conmedcorp
General & Plastic Surgery · 31d
Cleared Jul 30, 1999
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL...
K992218 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 29d
Cleared Jul 30, 1999
POWDERED LATEX STERILE SURGICAL GLOVES
K992219 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 29d
Cleared Jul 30, 1999
CRIT-LINE MONITOR III (CLM III)
K992227 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 28d
Cleared Jul 30, 1999
STAPLETAC BONE ANCHOR SYSTEM
K992277 · HWC
Influence, Inc.
Orthopedic · 23d
Cleared Jul 30, 1999
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
K992288 · GCJ
Tyco Intl. (Us), Inc.
General & Plastic Surgery · 23d
Cleared Jul 30, 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Jul 30, 1999
BLUNT TIP TROCAR PORT
K992353 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 16d
Cleared Jul 30, 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS,...
K992408 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 10d
Cleared Jul 29, 1999
BICORTICAL SCREW
K983120 · DZE
Oraltronics Marketing-Und Vertriebs GmbH
Dental · 328d
Cleared Jul 29, 1999
SD-100 SKYEAR THERMOMETER
K984506 · FLL
Skylark Device Co., Ltd.
General Hospital · 223d
Cleared Jul 29, 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 29, 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
K991533 · FGE
Peripheral Ave
Gastroenterology & Urology · 87d
Cleared Jul 29, 1999
BIOTHANE PATIENT RESTRAINT
K991591 · FMQ
Bioplastics
General Hospital · 83d
Cleared Jul 29, 1999
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
K991659 · GEX
Medart Corp.
General & Plastic Surgery · 76d
Cleared Jul 29, 1999
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
K992100 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 38d
Cleared Jul 29, 1999
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
K992177 · LZA
Pt. Berlian Glovindo
General Hospital · 31d
Cleared Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Jul 29, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992206 · LYZ
Shanghai China Star Corp
General Hospital · 29d
Cleared Jul 29, 1999
QUICK-SERTER, MODEL 395
K992300 · KZH
Medtronic Minimed
General Hospital · 21d
Cleared Jul 28, 1999
VOYAGER QUAD CANNULA
K983270 · DWF
Cardiothoracic Systems, Inc.
Cardiovascular · 314d
Cleared Jul 28, 1999
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · JOY
Chroma Vision Medical Systems, Inc.
Hematology · 247d
Cleared Jul 28, 1999
DADE BEHRING BFTII
K984501 · JPA
Dade Behring, Inc.
Hematology · 222d
Cleared Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · GIR
Precision Biologic
Hematology · 155d