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
127273–127296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1990
OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
K896821 · KOQ
North American Sterilization &...
Dental · 67d
Cleared Feb 09, 1990
LEUKOSILK(TM) SURGICAL TAPE
K896891 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 63d
Cleared Feb 09, 1990
MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER
K900043 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 09, 1990
MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
K900055 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 37d
Cleared Feb 09, 1990
MONOPOLAR NEEDLE ELECTRODE
K900098 · HLW
Oculinum, Inc.
Ophthalmic · 32d
Cleared Feb 09, 1990
QUARTZ FIBER CATHETERS AND SURGICAL TIPS
K900144 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 29d
Cleared Feb 09, 1990
OCULINUM INJECTION AMPLIFIER
K900279 · HLW
Oculinum, Inc.
Ophthalmic · 32d
Cleared Feb 09, 1990
NAS&P GRASPING FORCEPS & ASSOC. DEVICES
K900401 · KOQ
North American Sterilization &...
Dental · 11d
Cleared Feb 09, 1990
ZEFAZONE SUSCEPTIBILITY POWDER
K900455 · LOP
The Upjohn Co.
Microbiology · 10d
Cleared Feb 09, 1990
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
K900487 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 17d
Cleared Feb 08, 1990
DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
K892380 · DIF
Baxter Healthcare Corp
Toxicology · 308d
Cleared Feb 08, 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543 · DSI
Del Mar Avionics
Cardiovascular · 203d
Cleared Feb 08, 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · DTB
Medtronic Vascular
Cardiovascular · 176d
Cleared Feb 08, 1990
MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
K895639 · JWH
Zimmer, Inc.
Orthopedic · 142d
Cleared Feb 08, 1990
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
K896463 · ESD
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466 · DYG
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Feb 08, 1990
NICOLET REAL EAR ANALYZER
K896477 · ETW
Nicolet Instrument Corp.
Ear, Nose, Throat · 87d
Cleared Feb 08, 1990
LUXAR MODEL LX-20 MINILASE CO2 LASER
K896478 · GEX
Luxar Corp.
General & Plastic Surgery · 87d
Cleared Feb 08, 1990
AMYLASE REAGENT
K896650 · JFJ
Sigma Chemical Co.
Chemistry · 76d
Cleared Feb 08, 1990
AMRESCO CREATININE REAGENT #4316100
K896686 · CGX
American Research Products Co.
Chemistry · 72d
Cleared Feb 08, 1990
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
K896697 · KDQ
Deknatel, Inc.
General Hospital · 72d
Cleared Feb 08, 1990
MANIFOLD
K896804 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 69d
Cleared Feb 08, 1990
ENZYMUN TEST R T3
K896900 · CDP
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Feb 08, 1990
ENZYMUN TEST R HCG
K896901 · JHI
Boehringer Mannheim Corp.
Chemistry · 62d