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
110017–110040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1994
ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE
K934398 · GCJ
Transamerican Technologies Intl.
General & Plastic Surgery · 159d
Cleared Feb 14, 1994
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
K934525 · HFW
United States Surgical, A Division of...
Obstetrics & Gynecology · 150d
Cleared Feb 14, 1994
ENDODONTIC PULP CANAL SPREADER
K934714 · ELC
Excellence IN Endodontics, Inc.
Dental · 136d
Cleared Feb 14, 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Feb 14, 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Feb 14, 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · DTN
Gish Biomedical, Inc.
Cardiovascular · 76d
Cleared Feb 12, 1994
VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET
K926481 · GEI
Valleylab, Inc.
General & Plastic Surgery · 410d
Cleared Feb 10, 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · FXX
Johnson & Johnson Medical, Inc.
General Hospital · 762d
Cleared Feb 10, 1994
INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER
K922732 · DZE
Interpore Intl.
Dental · 612d
Cleared Feb 10, 1994
TRI-MED QUICK-STEP(TM) RECTAL TUBE
K924549 · GBT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 519d
Cleared Feb 10, 1994
VALVULOTOME
K925283 · MGZ
Intramed Laboratories, Inc.
Cardiovascular · 478d
Cleared Feb 10, 1994
BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND
K925776 · DZE
Nobelpharma USA, Inc.
Dental · 451d
Cleared Feb 10, 1994
MONOSTERYL
K926205 · EJL
Utensili Super Abrasivi
Dental · 428d
Cleared Feb 10, 1994
RETRACTOR RODS
K930032 · KNA
Thomasville Medical Assoc.
Obstetrics & Gynecology · 401d
Cleared Feb 10, 1994
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · GAD
Thomasville Medical Assoc.
General & Plastic Surgery · 384d
Cleared Feb 10, 1994
GUIDING CATHETER
K930476 · DQY
Boston Scientific Corp
Cardiovascular · 377d
Cleared Feb 10, 1994
3M PREVENTION FABRIC SURGICAL GOWN #78XX
K930681 · FYA
3M Health Care, Ltd.
General Hospital · 365d
Cleared Feb 10, 1994
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
K930980 · HWC
Instrument Makar, Inc.
Orthopedic · 350d
Cleared Feb 10, 1994
SOFTTOUCH II LANCET DEVICE
K931258 · FMK
Boehringer Mannheim Corp.
General & Plastic Surgery · 335d
Cleared Feb 10, 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936 · BZG
Allied Healthcare Products, Inc.
Anesthesiology · 239d
Cleared Feb 10, 1994
EZ-SPACER
K933090 · CAF
Airpharma, LLC
Anesthesiology · 231d
Cleared Feb 10, 1994
CANDELA GUIDEWIRE
K933268 · NWU
Candela Laser Corp.
Gastroenterology & Urology · 219d
Cleared Feb 10, 1994
THE BUCK
K933401 · JKA
Medical Implements, Inc.
Toxicology · 213d
Cleared Feb 10, 1994
UPGRADED SPIROMETER ST-90
K933511 · BTY
Futuremed Div. of Future Impex Corp.
Anesthesiology · 210d