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
130249–130272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1989
MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
K894362 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1989
DECONTAMINATING KIT, SKIN: M291
K894455 · MAC
Dept. of the Army
General Hospital · 21d
Cleared Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 15, 1989
DALE I.V. IDENTIFIER
K894586 · KMK
Dale Medical Products, Inc.
General Hospital · 22d
Cleared Aug 15, 1989
CHLAMYDIA (LGV-1)
K894625 · LKI
Bion Ent., Ltd.
Microbiology · 26d
Cleared Aug 11, 1989
CONDOMS
K880819 · HIS
Universal Trade, Inc.
Obstetrics & Gynecology · 532d
Cleared Aug 11, 1989
ANESTHETIC GAS MONITOR
K890446 · CBS
Bruel & Kjaer Instruments, Inc.
Anesthesiology · 196d
Cleared Aug 11, 1989
DENTANURSE
K891607 · EMA
The Irish Scene
Dental · 144d
Cleared Aug 11, 1989
PATIENT EXAM GLOVES (MFG. TA TA INDUSTRIAL CO.)
K892473 · LYY
Mccampbell Ent. Unltd., Inc.
General Hospital · 126d
Cleared Aug 11, 1989
TRACER DYNAMIC AXIAL FIXATION
K892638 · JEC
Tracer Medical
Orthopedic · 121d
Cleared Aug 11, 1989
XENOS MOBILECAM
K893379 · IYX
Xenos Medical Systems, Inc.
Radiology · 102d
Cleared Aug 11, 1989
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · KLT
Innotron of Oregon, Inc.
Chemistry · 98d
Cleared Aug 11, 1989
GE SIGNA ADVANTAGE
K893509 · LNH
GE Medical Systems
Radiology · 98d
Cleared Aug 11, 1989
T3 CLASP-BEAD EIA KIT
K893620 · CDP
Biotecx Laboratories, Inc.
Chemistry · 92d
Cleared Aug 11, 1989
OLYMPUS ISE MODULE FOR AU5000
K893628 · CGZ
Olympus Corp.
Chemistry · 92d
Cleared Aug 11, 1989
DIRECT BILIRUBIN REAGENT
K893730 · CIG
Medical Analysis Systems, Inc.
Chemistry · 86d
Cleared Aug 11, 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · JJQ
Quidel Corp.
Chemistry · 86d
Cleared Aug 11, 1989
LAURIER SANITARY NAPKIN
K893773 · HHD
Kao Corp.
Obstetrics & Gynecology · 81d
Cleared Aug 11, 1989
PEAK FLOW RATE METER
K893827 · FFG
Laytech Medical Co.
Gastroenterology & Urology · 79d
Cleared Aug 11, 1989
3D DENTAL DIAMOND ROTARY INSTRUMENTS
K893844 · DZP
Lustgarten Multi-Tech International,...
Dental · 78d
Cleared Aug 11, 1989
FLOCARE
K893875 · BYD
Mega-Tech Intl., Inc.
Anesthesiology · 77d
Cleared Aug 11, 1989
FD 350 DENTAL STOOL
K893945 · KLC
Oriola OY Finndent
Dental · 72d
Cleared Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 11, 1989
DERMACARE TIE HOLDER
K893995 · KGS
Dermacare
General & Plastic Surgery · 67d