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
87793–87816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1998
CHEMSTRIP 101 URINE ANALYZER
K983510 · KQO
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Dade Behring, Inc.
Immunology · 18d
Cleared Oct 26, 1998
COBE SMARXT TUBING AND CONNECTORS
K981613 · DWE
Cobe Cardiovascular, Inc.
Cardiovascular · 173d
Cleared Oct 26, 1998
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242
K982624 · IYE
Med-Tec,Inc.
Radiology · 90d
Cleared Oct 26, 1998
PATIENT WARMER- MODEL PW810
K982636 · ILY
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 89d
Cleared Oct 26, 1998
ADVANCED UROSCIENCE INJECTION NEEDLE
K982890 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 70d
Cleared Oct 26, 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · KMF
3M Company
General & Plastic Surgery · 70d
Cleared Oct 26, 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · KMF
3M Company
General & Plastic Surgery · 70d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
United States Surgical, A Division of...
Orthopedic · 45d
Cleared Oct 26, 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · HTN
Depuy Ace Medical Co.
Orthopedic · 39d
Cleared Oct 25, 1998
ZIPPIE GS, MODEL # EIZGS
K983639 · IOR
Sunrise Medical, Inc.
Physical Medicine · 9d
Cleared Oct 23, 1998
MG
K981791 · JGJ
Abbott Laboratories
Chemistry · 155d
Cleared Oct 23, 1998
SHIKANI-FRENCH SPEAKING VALVE
K982128 · JOH
Pilling Weck Surgical
Anesthesiology · 128d
Cleared Oct 23, 1998
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
K982604 · MQN
Walter Lorenz Surgical, Inc.
Dental · 88d
Cleared Oct 23, 1998
WINSTATION RETINAL IMAGER
K982689 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 81d
Cleared Oct 23, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE
K982725 · ITX
Olympus America, Inc.
Radiology · 79d
Cleared Oct 23, 1998
BIO PONTOSTAR
K983077 · EJT
Bego U.S.A.
Dental · 51d
Cleared Oct 23, 1998
BEGOPAL
K983078 · EJS
Bego U.S.A.
Dental · 51d
Cleared Oct 23, 1998
PLATINLLOYD 100
K983079 · EJT
Bego U.S.A.
Dental · 51d
Cleared Oct 22, 1998
ATLANT'S
K974395 · IRP
Grad-Line Corp.
Physical Medicine · 335d
Cleared Oct 22, 1998
SLE ELECTRODES AND ACCESSORIES
K980410 · GXY
Specialized Laboratory Equipment, Ltd.
Neurology · 261d
Cleared Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH...
K980590 · JAQ
Varian Medical Systems, Inc.
Radiology · 247d
Cleared Oct 22, 1998
EXMOOR MYRINGOTOMY KIT
K980828 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 233d
Cleared Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209 · MVM
The Binding Site, Ltd.
Immunology · 203d