Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
168025–168048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1980
SERUM CREATININE
K800219 · CGX
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · JIT
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 22d
Cleared Feb 26, 1980
ABCO EXAMINATION LAMP (GOOSENECK TYPE)
K800230 · KZF
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231 · FNM
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO MIDSTREAM URINE COLLECTION SET
K800233 · FMH
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K800234 · JOL
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO CONNECTING TUBES PRECUT LENGTHS
K800235 · BYY
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
MICRO MEDICAL DATA SYSTEM
K800241 · JQP
Micro/Tel., Inc.
Chemistry · 21d
Cleared Feb 26, 1980
EMIT -D.A.U. CANNABINOID URINE ASSAY
K800246 · LAT
Syva Co.
Toxicology · 21d
Cleared Feb 26, 1980
EMIT -D.A.U. CANNABINOID URINE CALIBS.
K800247 · DLJ
Syva Co.
Toxicology · 21d
Cleared Feb 26, 1980
AUDIONICS PB MAX HEARING AID
K800269 · ESD
Audionics Corp.
Ear, Nose, Throat · 20d
Cleared Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 20d
Cleared Feb 26, 1980
COROMETRICS MEDICAL SYSTEMS 220 PH SYS.
K800271 · CHL
Transidyne General Corp.
Chemistry · 20d
Cleared Feb 26, 1980
RELY DEODERANT TAMPON
K800272 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 19d
Cleared Feb 26, 1980
OTICON MODEL E17VF EARETTE HEARING AID
K800283 · ESD
Oticon Corp.
Ear, Nose, Throat · 18d
Cleared Feb 26, 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · FMG
Abbott Laboratories
General Hospital · 18d
Cleared Feb 26, 1980
LDC SPECTROMONITOR III
K800289 · KIE
Laboratory Data Control
Toxicology · 15d
Cleared Feb 26, 1980
SPECIMEN COLLECTION PAN
K800309 · FMH
Sage Products, Inc.
General Hospital · 14d
Cleared Feb 26, 1980
OTICON MODEL E19VF EARETTE HEARING AID
K800316 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Feb 26, 1980
VOLU-SOL EA-50 STAIN
K800322 · HZJ
Volu Sol Medical Industries
Pathology · 14d
Cleared Feb 26, 1980
VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65
K800325 · HZJ
Volu Sol Medical Industries
Pathology · 14d
Cleared Feb 26, 1980
PHONIC EAR, MODEL 841L
K800340 · ESD
Hc Electronics
Ear, Nose, Throat · 11d
Cleared Feb 25, 1980
THEOPHYLLINE RIASSAY
K792062 · LCA
Ria Diagnostics
Toxicology · 133d