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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157801–157824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1983
E-Z JECTOR
K830042 · EJI
Innovators, Inc.
Dental · 19d
Cleared Jan 26, 1983
MOLNLYCKE MESALT STERILE DRESSING
K830051 · FRO
Lada Intl., Inc.
General & Plastic Surgery · 16d
Cleared Jan 26, 1983
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · CAK
Travenol Laboratories, S.A.
General Hospital · 19d
Cleared Jan 24, 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342 · DSP
Datascope Corp.
Cardiovascular · 77d
Cleared Jan 24, 1983
ZIMMER GREAT TOE
K823405 · KWH
Zimmer, Inc.
Orthopedic · 70d
Cleared Jan 24, 1983
GENESIS B-HCG
K823753 · JHI
Armkel, LLC
Chemistry · 41d
Cleared Jan 24, 1983
MEDELA NAMUAL BREAST PUMP
K823840 · HGY
Medela, Inc.
Obstetrics & Gynecology · 34d
Cleared Jan 24, 1983
URIC ACID TEST
K823846 · KNK
Scalavo, Inc.
Chemistry · 34d
Cleared Jan 24, 1983
VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER
K827577
Randwal Instrument Co., Inc.
Radiology · 35d
Cleared Jan 24, 1983
MEDELA SUCTION PUMP
K830012 · HDB
Medela, Inc.
Obstetrics & Gynecology · 21d
Cleared Jan 24, 1983
TRACTION 230
K830088 · ITH
Tri W-G, Inc.
Physical Medicine · 13d
Cleared Jan 24, 1983
MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM
K837030
Meditec, Inc.
Radiology · 35d
Cleared Jan 21, 1983
LATEX PENROSE TUBING
K822755
American Hospital Supply Corp.
General & Plastic Surgery · 135d
Cleared Jan 21, 1983
KF-E SERIES HOLLOW FIBER DIALYZER
K823069 · KOC
Medisystems Corp.
Gastroenterology & Urology · 94d
Cleared Jan 21, 1983
BERKELEY CHAIR
K823085 · ITI
Berkeley Electric Wheelchair Co.
Physical Medicine · 94d
Cleared Jan 21, 1983
RCI EARMATE
K823089 · ESD
Rci, Inc.
Ear, Nose, Throat · 94d
Cleared Jan 21, 1983
SKIN GALVANOMETER
K823194 · HCJ
Spelson Research Laboratories, Inc.
Neurology · 87d
Cleared Jan 21, 1983
BACK ON TRACK INVERSION THERAPY & EXER
K823236 · ION
Lossing Orthopedic, Inc.
Physical Medicine · 81d
Cleared Jan 21, 1983
SIDEARM Y-ADAPTOR
K823243 · DQO
American Edwards Laboratories
Cardiovascular · 81d
Cleared Jan 21, 1983
HELIOSIT-ORTHODONTIC
K823409 · DYH
Vivadent (Usa), Inc.
Ophthalmic · 67d
Cleared Jan 21, 1983
VON WILLEBRAND FACTOR ASSAY
K823453 · GGP
General Diagnostics
Hematology · 65d
Cleared Jan 21, 1983
MOBILIMB-CPM UPPER/LOWER LIMB DEVICE
K823495 · BXB
Synthes (Usa)
Physical Medicine · 59d
Cleared Jan 21, 1983
ZEE SPHYGMOMANOMETER
K823501 · DXN
Zee Medical Products Co., Inc.
Cardiovascular · 58d
Cleared Jan 21, 1983
MICRO-HEMATOCRIT CENTRIFUGE 335/336
K823558 · JPI
Fisher Scientific Co., LLC
Hematology · 50d