FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127873–127896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 08, 1990
METAL URETERAL BASKET STONE DISLODGER
K896992 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 08, 1990
COULTER PHOSPHORUS REAGENT
K900215 · CEO
Coulter Corp.
Chemistry · 22d
Cleared Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
K900216 · CJE
Coulter Corp.
Chemistry · 22d
Cleared Feb 07, 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · DPT
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Feb 06, 1990
ADULT RESECTOSCOPE
K890328 · HIH
Circon Video
Obstetrics & Gynecology · 379d
Cleared Feb 06, 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · EMA
Confi-Dental Products Co.
Dental · 186d
Cleared Feb 06, 1990
HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)
K896546 · FRN
Block Medical, Inc.
General Hospital · 81d
Cleared Feb 06, 1990
UNIVERSAL POOLE SUCTION TUBE
K896556 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-FLEXIBLE TYPE
K896557 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-RIGID TYPE
K896558 · GCX
Westmark, Sterile Packing Systems,...
General Hospital · 81d