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
159289–159312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1982
POWERED MUSCLE STIMULATOR
K821511 · EPF
High Country Ent.
Ear, Nose, Throat · 88d
Cleared Aug 16, 1982
EXACON THERMOMETER SYSTEM 8000
K821555 · FLL
Sat Export Engineering & Trading
General Hospital · 83d
Cleared Aug 16, 1982
EXACON TEMP. PROBES SYSTEM 8000-#TH-103
K821556 · FLL
Sat Export Engineering & Trading
General Hospital · 83d
Cleared Aug 16, 1982
PHOTOTHERAPY EYE PROTECTION FOR INFANTS
K821765 · HOY
Russell Terry Co.
Ophthalmic · 63d
Cleared Aug 16, 1982
I.V. SENTINEL
K821823 · FLN
The John Bunn Co.
General Hospital · 55d
Cleared Aug 16, 1982
SECHRIST MODEL 990 JET VENTILATOR
K821930 · CBK
Sechrist Industries, Inc.
Anesthesiology · 48d
Cleared Aug 16, 1982
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936 · KLK
Critikon Company, LLC
Anesthesiology · 48d
Cleared Aug 16, 1982
TITAN GEL SERUM CONTROL
K821982 · JJY
Helena Laboratories
Chemistry · 41d
Cleared Aug 16, 1982
MEDI + BIO SAFE STEAM STERILIZ. INDICAT
K821997 · JOJ
Arvey Corp.
General Hospital · 40d
Cleared Aug 16, 1982
LARGE VOLUME CLOSED WOUND SUCTION DRAIN
K822032 · GCY
American Heyer Schulte
General & Plastic Surgery · 35d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · KOC
Gambro, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 16, 1982
KAM SUCKER
K822065 · KDC
The Anspach Effort, Inc.
General & Plastic Surgery · 33d
Cleared Aug 16, 1982
U-100 INSULIN SYRINGE
K822083 · FMF
Terumo Medical Corp.
General Hospital · 35d
Cleared Aug 16, 1982
DENTAL MATRIX BAND
K822094 · DZN
Dentsply Intl.
Dental · 31d
Cleared Aug 16, 1982
ANESTHESIA BREATHING BAG, VARIOUS SIZES
K822116 · BTC
Life Design Systems, Inc.
Anesthesiology · 28d
Cleared Aug 16, 1982
LASER BRONCHOSCOPE
K822136 · EOQ
Laser Industries of Tel Aviv
Ear, Nose, Throat · 27d
Cleared Aug 16, 1982
MYRINGOTOMY KNIFE (VARIOUS TYPES)
K822162 · JYP
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT CHISELS
K822165 · JYE
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ANTRUM TROCARS
K822168 · KTE
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
MICROSURGICAL EAR PICKS
K822176 · JYT
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
MOUTH GAGS
K822183 · KBN
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT METAL TONGUE DEPRESSORS
K822184 · KBL
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
BECKMAN ADENOID CURRETTE
K822189 · KBJ
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT ELEVATORS
K822190 · KAD
Kelleher Corp.
Ear, Nose, Throat · 24d