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
134737–134760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 26d
Cleared Jul 13, 1988
JEDMED/POLACK KERATOSCOPE HS/SL
K882618 · HLR
Gamut Ent.
Ophthalmic · 19d
Cleared Jul 12, 1988
ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
K874253 · LNK
Minnesota Laser Corp.
Gastroenterology & Urology · 266d
Cleared Jul 12, 1988
ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
K874255 · LNK
Minnesota Laser Corp.
Gastroenterology & Urology · 266d
Cleared Jul 12, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K874938 · DSB
Sp Innovations, Inc.
Cardiovascular · 221d
Cleared Jul 12, 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · DSI
Mennen Medical, Inc.
Cardiovascular · 109d
Cleared Jul 12, 1988
PROXIMA 1 PH MONITOR
K881706 · FFT
Technomanagement, Inc. C/O C.G.
Gastroenterology & Urology · 84d
Cleared Jul 12, 1988
SPECIAL PROCEDURES BASE UNIT MODEL 500
K881713 · FMT
Gempco, Inc.
General Hospital · 82d
Cleared Jul 12, 1988
MSI 4000 SERIES BED
K881782 · FNL
Med Service, Inc.
General Hospital · 77d
Cleared Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · CGA
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Jul 12, 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · DIO
Syva Co.
Toxicology · 64d
Cleared Jul 12, 1988
ESCORT - PORTABLE PATIENT MONITOR
K881986 · DXH
Medical Data Electronics
Cardiovascular · 61d
Cleared Jul 12, 1988
HARMONY HEARING AID MODELS LP, M, HO, HF, & C
K882005 · ESD
Harmony Hearing Aids, Co.
Ear, Nose, Throat · 60d
Cleared Jul 12, 1988
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
K882045 · LDF
Cordis Leads, Inc.
Cardiovascular · 57d
Cleared Jul 12, 1988
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
K882161 · FNM
Ssi Medical Services, Inc.
General Hospital · 50d
Cleared Jul 12, 1988
EMIT HVA PHENCYCLIDINE ASSAY
K882179 · LCL
Syva Co.
Toxicology · 49d
Cleared Jul 12, 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 42d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
K882300 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
K882301 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
K882302 · FPA
Y
General Hospital · 40d
Cleared Jul 12, 1988
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · FLL
Abco Dealers, Inc.
General Hospital · 39d
Cleared Jul 12, 1988
ACCRAASSAY RID KITS
K882369 · DEW
Icn Immunobiologicals
Immunology · 34d
Cleared Jul 12, 1988
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K882513 · DSI
Cardiac Resucitator Corp.
Cardiovascular · 40d
Cleared Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
K882534 · LIR
Abbott Laboratories
Microbiology · 21d