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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
106705–106728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1994
LASER PHOTONICS ML755 DERMABLASER
K934501 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 350d
Cleared Aug 30, 1994
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711 · MDB
Organon Teknika Corp.
Microbiology · 273d
Cleared Aug 30, 1994
REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS
K936224 · JOH
Mallinckrodt Medical Tpi, Inc.
Anesthesiology · 266d
Cleared Aug 30, 1994
BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK
K940697 · FPA
Bd Becton Dickinson Vacutainer...
General Hospital · 195d
Cleared Aug 30, 1994
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
K941001 · GIS
Diagnostic Specialties
Hematology · 182d
Cleared Aug 30, 1994
PIKOS E 01-B
K941937 · DXY
Biotronik, Inc.
Cardiovascular · 131d
Cleared Aug 30, 1994
CEDIA DAU BARBITURATE ASSAY
K942436 · DIS
Microgenics Corp.
Toxicology · 124d
Cleared Aug 29, 1994
PESSARY FLEXIBLE SILICONE DONUT RING
K920747 · HHW
Bioteque America, Inc.
Obstetrics & Gynecology · 922d
Cleared Aug 29, 1994
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
K923529 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 774d
Cleared Aug 29, 1994
O BUTMENT ES IMPLANT
K923889 · DZE
"O" Co., Inc.
Dental · 755d
Cleared Aug 29, 1994
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
K925606 · HMR
Chiron Vision Corp.
Ophthalmic · 662d
Cleared Aug 29, 1994
THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM
K930506 · IYE
Pinecliff Assoc.
Radiology · 574d
Cleared Aug 29, 1994
STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY
K931731 · HPL
Storz Instrument Co.
Ophthalmic · 509d
Cleared Aug 29, 1994
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K931763 · FAS
Olympus Corp.
Gastroenterology & Urology · 508d
Cleared Aug 29, 1994
LIFE-TELL T.S.S.
K932046 · DXH
Raco Products Co.
Cardiovascular · 489d
Cleared Aug 29, 1994
SAVE-T-BREATH AMBILICAL CORD CLAMP
K933763 · HFW
Save-T-Breath Distributors C.C.
Obstetrics & Gynecology · 391d
Cleared Aug 29, 1994
DR KOOL
K935841 · ILO
Toronto Medical Corp.
Physical Medicine · 265d
Cleared Aug 29, 1994
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS
K940908 · DZP
Dunhall Pharmaceuticals, Inc.
Dental · 186d
Cleared Aug 29, 1994
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · EMA
Dentsply Intl.
Dental · 185d
Cleared Aug 29, 1994
50 DEGREE HRI PRISM LENS
K941420 · HJK
Ocular Instruments, Inc.
Ophthalmic · 159d
Cleared Aug 29, 1994
IN-ROOM AND SHARPSTAR
K941991 · MMK
Sage Products, Inc.
General Hospital · 126d
Cleared Aug 29, 1994
ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV
K942742 · DYH
Wallace A. Erickson & Co.
Dental · 80d
Cleared Aug 29, 1994
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
K943191 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 55d
Cleared Aug 29, 1994
SONICATOR 730
K943469 · IMG
Mettler Electronics Corp.
Physical Medicine · 41d