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
109897–109920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1994
ASTROGLIDE
K935299 · KMJ
Biofilm, Inc.
General Hospital · 108d
Cleared Feb 18, 1994
CAPINTEC CRC 35R
K935539 · KPT
Capintec Instruments, Inc.
Radiology · 94d
Cleared Feb 18, 1994
SYRIGENE PRE-FILLED SYRINGE
K935669 · JDL
Regulatory & Marketing Services, Inc.
General Hospital · 84d
Cleared Feb 18, 1994
DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS
K935870 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 74d
Cleared Feb 17, 1994
MALLAWANY ATRAUMATIC TISSUE FORCEPS
K922248 · HET
Numed Technologies, Inc.
Obstetrics & Gynecology · 645d
Cleared Feb 17, 1994
TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT
K922343 · JKA
Tri-Tech, Inc.
Toxicology · 639d
Cleared Feb 17, 1994
MIC PEG TUBE
K924065 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 570d
Cleared Feb 17, 1994
ARTHRO FMS 4
K925160 · HRX
Orthoconcept, Inc.
Orthopedic · 492d
Cleared Feb 17, 1994
NUTRICARE ENTERAL FEEDING TUBE
K925261 · KNT
Entracare Corp.
Gastroenterology & Urology · 486d
Cleared Feb 17, 1994
AUTOREF LENSMETER RL-10
K925304 · HKO
Canon USA, Inc.
Ophthalmic · 484d
Cleared Feb 17, 1994
PRIMODENT ACRYLIC TEETH
K926070 · ELM
I.T.C. Ent.
Dental · 443d
Cleared Feb 17, 1994
KIRWAN IRRIGATION/ASPIRATION HANDPIECE
K930113 · HMX
Kirwan Surgical Products, Inc.
Ophthalmic · 402d
Cleared Feb 17, 1994
PATIENT PREOPERATIVE PREP TRAY, SINGLE USE
K930270 · LRO
Professional Medical Products, Inc.
General & Plastic Surgery · 394d
Cleared Feb 17, 1994
CRYPTO-LEX SYSTEM
K930418 · GMD
Trinity Laboratories, Inc.
Microbiology · 387d
Cleared Feb 17, 1994
ADV400 TOE CPM
K930780 · BXB
Advanced Kinetics, Inc.
Physical Medicine · 366d
Cleared Feb 17, 1994
X-20 AIR SUPPORT BED
K931168 · INX
American Life Support Technology, Inc.
Physical Medicine · 346d
Cleared Feb 17, 1994
BATTERY PACK #1005NC
K931348 · BTA
Portable Power Systems, Inc.
General & Plastic Surgery · 337d
Cleared Feb 17, 1994
REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
K931483 · IZL
Portable Power Systems, Inc.
Radiology · 330d
Cleared Feb 17, 1994
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
K931484 · BZD
Portable Power Systems, Inc.
Anesthesiology · 330d
Cleared Feb 17, 1994
6.5 MM CANCELLOUS BONE SCREW
K931665 · HWC
Encore Orthopedics, Inc.
Orthopedic · 318d
Cleared Feb 17, 1994
RESECTOSCOPE SHEATH
K931994 · HIH
Olympus Corp.
Obstetrics & Gynecology · 300d
Cleared Feb 17, 1994
I.V. START KIT
K932071 · FOZ
Clinipad Corp.
General Hospital · 295d
Cleared Feb 17, 1994
LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE
K932540 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 267d
Cleared Feb 17, 1994
BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
K932823 · DXN
Portable Power Systems, Inc.
Cardiovascular · 253d