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
120265–120288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434 · GZI
Medtronic Vascular
Neurology · 374d
Cleared Aug 09, 1991
LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA
K905291 · KGI
Lunar
Radiology · 256d
Cleared Aug 09, 1991
JEJUNO-CATH KIT
K905677 · FPD
Health Improvement Assoc.
Gastroenterology & Urology · 233d
Cleared Aug 09, 1991
BARD HYDROGEL-COATED FOLEY CATHETERS
K910195 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 205d
Cleared Aug 09, 1991
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
K910197 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 205d
Cleared Aug 09, 1991
HGM COMBINATION ND:YAG & SOLID STATE GREEN
K910272 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 198d
Cleared Aug 09, 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · DTB
Possis Medical, Inc.
Cardiovascular · 182d
Cleared Aug 09, 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · DTD
Biotronik, GmbH & Co.
Cardiovascular · 148d
Cleared Aug 09, 1991
CUSTOM PROCEDURE TRAY
K911565 · KKX
Vanguard Medical Concepts, Inc.
General Hospital · 122d
Cleared Aug 09, 1991
XYZ CRANK IMAGING TABLE
K911691 · IYZ
Med-Tron Products, Inc.
Radiology · 115d
Cleared Aug 09, 1991
SIMPLATE PEDIATRIC
K911745 · JCA
Organon Teknika Corp.
Hematology · 113d
Cleared Aug 09, 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · BZD
Respironics, Inc.
Anesthesiology · 105d
Cleared Aug 09, 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · DTN
Shiley, Inc.
Cardiovascular · 102d
Cleared Aug 09, 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · BTM
Puritan Bennett Corp.
Anesthesiology · 98d
Cleared Aug 09, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K912095 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Aug 09, 1991
ACS LIQUID THROMBOPLASTIN
K912102 · GJS
Analytical Control Systems, Inc.
Hematology · 88d
Cleared Aug 09, 1991
MAJOR BASIN TRAY
K912104 · FSM
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 88d
Cleared Aug 09, 1991
LACERATION TRAY
K912117 · MCY
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 88d
Cleared Aug 09, 1991
TBD KERATOSCOPE
K912130 · HLQ
Alcon Laboratories
Ophthalmic · 87d
Cleared Aug 09, 1991
RADIOACTIVE IODINE-125 SOURCES
K912170 · IWI
Best Industries
Radiology · 85d
Cleared Aug 09, 1991
INTRAVASCULAR CATHETER SECURMENT DEVICE
K912211 · KMK
Inman Liebelt Corp.
General Hospital · 81d
Cleared Aug 09, 1991
VACU 2
K912302 · EJS
Metalor Dental USA Corp.
Dental · 80d
Cleared Aug 09, 1991
STANDARD S3
K912305 · EJS
Metalor Dental USA Corp.
Dental · 80d
Cleared Aug 09, 1991
STANDARD S31
K912307 · EJS
Metalor Dental USA Corp.
Dental · 80d