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
105889–105912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1994
TYPE I GLASS IONOMER CEMENT
K942808 · EMA
Mion International Corp.
Dental · 141d
Cleared Nov 03, 1994
ORAFIX SPECIAL DENTURE ADHESIVE
K943486 · KOO
Smithkline Beecham Corp.
Dental · 107d
Cleared Nov 03, 1994
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664 · MEB
Baxter Healthcare Corp
General Hospital · 98d
Cleared Nov 03, 1994
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
K943776 · HIN
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 93d
Cleared Nov 03, 1994
CURVED ENDOPHOTOCOAGULATOR LASER PROBE
K944470 · GEX
Mnlase, Inc.
General & Plastic Surgery · 55d
Cleared Nov 03, 1994
STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE
K944471 · GEX
Mnlase, Inc.
General & Plastic Surgery · 55d
Cleared Nov 03, 1994
SEALAPEX
K944480 · EMA
Sybron Dental Specialties, Inc.
Dental · 51d
Cleared Nov 03, 1994
DW250 #91
K944557 · EJT
Rms Div.
Dental · 48d
Cleared Nov 03, 1994
MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944625 · GEX
Mnlase, Inc.
General & Plastic Surgery · 44d
Cleared Nov 03, 1994
MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944626 · GEX
Mnlase, Inc.
General & Plastic Surgery · 44d
Cleared Nov 03, 1994
MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER
K944627 · GEX
Mnlase, Inc.
General & Plastic Surgery · 44d
Cleared Nov 03, 1994
MODEL 220-SS LASER DELIVERY PROBE
K944628 · GEX
Mnlase, Inc.
General & Plastic Surgery · 44d
Cleared Nov 03, 1994
MODEL 230-SAC LASER DELIVERY PROBE
K944629 · GEX
Mnlase, Inc.
General & Plastic Surgery · 44d
Cleared Nov 03, 1994
SURGI-LINK LAPAROSCOPIC ELECTRODES
K945030 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 21d
Cleared Nov 02, 1994
MR7000 WITH TIME MANAGER SOFTWARE (TMS)
K934111 · JQP
Dynatech Laboratories, Inc.
Microbiology · 456d
Cleared Nov 02, 1994
BUSSE ISOLATION AND PROCEDURAL MASKS
K940720 · FXX
Busse Hospital Disposables, Inc.
General Hospital · 257d
Cleared Nov 02, 1994
SOLOR CARE TECHNOLOGIES CORPORATION OPIATES
K941041 · DJG
Solar Technologies Corp.
Toxicology · 240d
Cleared Nov 02, 1994
MICROVASIVE INJECTION GOLD PROBE
K942301 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 174d
Cleared Nov 02, 1994
SYNCHRON CX3 DELTA
K942676 · JJF
Beckman-Diagnostic Systems Group
Chemistry · 149d
Cleared Nov 02, 1994
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
K942753 · EYZ
Researched, Novel Medical Devices...
Gastroenterology & Urology · 145d
Cleared Nov 02, 1994
MAHE INSTRUMENTS
K942821 · GEI
Mahe-Medizintechnik
General & Plastic Surgery · 141d
Cleared Nov 02, 1994
SENTRY INSERTION TRAY
K942827 · FOS
Sentry Medical Products, Inc.
General Hospital · 141d
Cleared Nov 02, 1994
SUMMIT TOTAL HIP SYSTEM
K942891 · MEH
Kirschner Medical Corp.
Orthopedic · 135d
Cleared Nov 02, 1994
SAS SALMONELLA H D ANTISERUM
K943400 · GRM
Sa Scientific, Inc.
Microbiology · 111d