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
134689–134712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1988
LECTROBRASIVE(R) E2401
K882646 · GEI
Valleylab, Inc.
General & Plastic Surgery · 21d
Cleared Jul 18, 1988
FIBER OPTIC LIGHT SOURCE CAT. #E9100
K882742 · GEI
Valleylab, Inc.
General & Plastic Surgery · 17d
Cleared Jul 18, 1988
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767 · GKH
Toa Medical Electronics USA, Inc.
Hematology · 12d
Cleared Jul 18, 1988
MCCOY'S 5A MEDIUM, CATA NO. 200-2026
K882773 · KIT
J R Scientific
Pathology · 13d
Cleared Jul 18, 1988
COON'S MEDIUM F-12, CATALOG NO. 200-2066
K882789 · KIT
J R Scientific
Pathology · 12d
Cleared Jul 18, 1988
PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE
K882793 · GAF
Pmt Corp.
General & Plastic Surgery · 12d
Cleared Jul 18, 1988
LUER-LOK MULTIFLO ADAPTER
K882797 · FPA
Deseret Medical, Inc.
General Hospital · 12d
Cleared Jul 18, 1988
MULTIFLO ADAPTER
K882798 · FPA
Deseret Medical, Inc.
General Hospital · 12d
Cleared Jul 18, 1988
MEDIUM 199, CATALOG NO. 200-2032
K882806 · KIT
J R Scientific
Pathology · 11d
Cleared Jul 18, 1988
DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2011
K882807 · KIT
J R Scientific
Pathology · 11d
Cleared Jul 18, 1988
RPMI-1640 MEDIUM, CATALOG NO. 200-2076
K882808 · KIT
J R Scientific
Pathology · 11d
Cleared Jul 15, 1988
MEDSURG ACUTE DIALYSIS TRAY
K880778 · LFJ
Medsurg Industries, Inc.
Gastroenterology & Urology · 140d
Cleared Jul 15, 1988
AMDENT MODEL 830 ULTRASONIC SCALER
K880940 · ELC
Pathway Products, Inc.
Dental · 130d
Cleared Jul 15, 1988
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
K880979 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 129d
Cleared Jul 15, 1988
ACKRAD H/S PROCEDURE TRAY
K881680 · HIG
Ackrad Laboratories
Obstetrics & Gynecology · 87d
Cleared Jul 15, 1988
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · ETN
Downs Surgical , Ltd.
Ear, Nose, Throat · 81d
Cleared Jul 15, 1988
MULTI-FLEX TABLE--MODEL 200
K881804 · JFB
Slenderizers Equipment Mfg., Inc.
Physical Medicine · 78d
Cleared Jul 15, 1988
PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT
K881890 · EMA
Specialites Septodont
Dental · 71d
Cleared Jul 15, 1988
COVER UP
K881914 · EMA
Parkell
Dental · 67d
Cleared Jul 15, 1988
LIGHT-CURED ZIONOMER CEMENT
K881918 · EMA
Den-Mat Corp.
Dental · 67d
Cleared Jul 15, 1988
JEDMED MAXIM ENT CABINET
K881958 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 66d
Cleared Jul 15, 1988
NOSE BRACE
K882131 · LWF
Allied Advanced Technologies (Aat)
Ear, Nose, Throat · 56d
Cleared Jul 15, 1988
AMORPHUS SILK BY DENTRAX
K882400 · EBF
Dale T. Dupuis
Dental · 35d
Cleared Jul 15, 1988
ACID ETCH GEL
K882576 · EBF
Pulpdent Corp. of America
Dental · 23d