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
160969–160992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1982
ENZYMUNE-TEST INSULIN
K821374 · CFP
Icl Scientific
Chemistry · 18d
Cleared May 28, 1982
EMIT-TOX ACETAMINOPHEN ASSAY
K821379 · LDP
Syva Co.
Toxicology · 18d
Cleared May 28, 1982
CHEMISTRY CONTROL/STANDARD
K821382 · JJY
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared May 28, 1982
SERO/TEX LE TEST
K821385 · DHC
Texas Immunology, Inc.
Immunology · 18d
Cleared May 28, 1982
MACRO-VUE CARD TEST, NETILMICIN
K821399 · LCE
Bd Becton Dickinson Vacutainer...
Toxicology · 17d
Cleared May 28, 1982
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · DCN
Syva Co.
Immunology · 16d
Cleared May 28, 1982
DIGITAL BLOOD PRESSURE METER
K821437 · DXN
Timex Medical Products Corp.
Cardiovascular · 15d
Cleared May 28, 1982
DURAZYME CPK
K821452
American Monitor Corp.
Chemistry · 14d
Cleared May 28, 1982
ULTRAZYME PLUS AMYL #65031&64982
K821459 · JFJ
Emd Chemicals, Inc.
Chemistry · 10d
Cleared May 28, 1982
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
K821488 · KNN
Electro-Catheter Corp.
Physical Medicine · 10d
Cleared May 28, 1982
TRACKER-2 CHANNEL ECG TAPE RECORDER
K821516 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 7d
Cleared May 28, 1982
SYRINGE IRRIGATING
K821530 · KYZ
Medcare Disp Products, Inc.
General Hospital · 7d
Cleared May 28, 1982
HENKE DISPOSABLE SYRINGE
K821537 · FMF
C. B. Dumont Company, Inc.
General Hospital · 4d
Cleared May 27, 1982
BARD CONTOUR LINK S.K.I. KNEE SYS
K820002 · HRY
C.R. Bard, Inc.
Orthopedic · 143d
Cleared May 27, 1982
FAST VIOLET B
K821038 · JTS
Dms Laboratories
Microbiology · 44d
Cleared May 27, 1982
PNEUMO DRAIN T.M. RECORDER #PD-800
K821160 · GCX
Sugen Industries, Inc.
General Hospital · 35d
Cleared May 27, 1982
MEDCO CUSTOM EAR PROTECTOR MOLD KIT
K821187 · EWD
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 30d
Cleared May 27, 1982
THUMB DRESSING FORCEPS
K821267 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
TRACHEOSTOMY CARE TRAYS
K821269 · EQN
Intermed, Inc.
Ear, Nose, Throat · 24d
Cleared May 27, 1982
HALSTEAD MOSQUITO FORCEPS
K821274 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
KELLY FORCEPS CURVED 5 1/2
K821277 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
HARTMAN FORCEPS STRAIGHT 3 1/2
K821278 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
HALSTEAD FORCEPS (MOSQUITO) 5
K821279 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d
Cleared May 27, 1982
TISSUE FORCEPS
K821280 · GEN
Conphar, Inc.
General & Plastic Surgery · 24d