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
88321–88344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1998
HEMOSITE TEST SYSTEM
K973649 · KHG
Gds Technology, LLC
Microbiology · 340d
Cleared Aug 31, 1998
VAPAMASTA 6
K980489 · CAD
Medical Industrial Equipment
Anesthesiology · 203d
Cleared Aug 31, 1998
FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
K981066 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 160d
Cleared Aug 31, 1998
THE BAGNOLI-4 EMG SYSTEM
K981934 · HCC
Delsys, Inc.
Neurology · 90d
Cleared Aug 31, 1998
MP-3 POWER BASE CHAIR
K982066 · ITI
Merits Health Products., Inc.
Physical Medicine · 81d
Cleared Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · JDW
Howmedica Corp.
Orthopedic · 80d
Cleared Aug 31, 1998
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
K982141 · DXE
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Aug 31, 1998
SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K982155 · MBI
Influence, Inc.
Orthopedic · 74d
Cleared Aug 31, 1998
SCOUT
K982158 · ITI
Burke, Inc.
Physical Medicine · 73d
Cleared Aug 31, 1998
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR...
K982248 · LPH
Howmedica, Inc.
Orthopedic · 66d
Cleared Aug 31, 1998
DEPUY ACE TIMAX PILON PLATE
K982347 · HRS
Depuy Ace Medical Co.
Orthopedic · 56d
Cleared Aug 31, 1998
MANUAL WHEELCHAIR
K982607 · IOR
G. Hirsch and Co., Inc.
Physical Medicine · 35d
Cleared Aug 31, 1998
UNI/MONOPOLAR HF CABLE
K982677 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 31d
Cleared Aug 31, 1998
PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
K982900 · MAI
Depuy, Inc.
Orthopedic · 14d
Cleared Aug 28, 1998
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
K981011 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 163d
Cleared Aug 28, 1998
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING...
K981180 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 149d
Cleared Aug 28, 1998
AMY
K981653 · JFJ
Abbott Laboratories
Chemistry · 109d
Cleared Aug 28, 1998
LIGASURE VESSEL SEALING SYSTEM
K981916 · GEI
Valleylab, Inc.
General & Plastic Surgery · 88d
Cleared Aug 28, 1998
ACCU-CHECK VOICEMATE
K982079 · LFR
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Aug 28, 1998
CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL...
K982740 · DYB
Cordis Webster, Inc.
Cardiovascular · 22d
Cleared Aug 28, 1998
MODIFICATION TO EBI SPINELINK SYSTEM
K982908 · KWP
Electro-Biology, Inc.
Orthopedic · 10d
Cleared Aug 27, 1998
CAOW HEMOSTASIS SYSTEM
K972689 · DXC
Anlam Corp.
Cardiovascular · 406d
Cleared Aug 27, 1998
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS...
K973943 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 315d
Cleared Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090 · MSE
Fresenius Medical Care North America
Gastroenterology & Urology · 302d