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
84169–84192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1999
SCAREASE SHEETS & SCAREASE GEL
K991970 · MDA
Pillar Surgical
General & Plastic Surgery · 136d
Cleared Oct 25, 1999
VENTIL-A ORAL PROTECTOR
K992269 · JXL
Somatics, Inc.
Neurology · 111d
Cleared Oct 25, 1999
XRT 600 R/F, WRF 0600
K992603 · JAA
Wuestec Medical, Inc.
Radiology · 83d
Cleared Oct 25, 1999
AMIGO MODEL 680000 (AMIGO EXCITE F 350)
K992619 · ITI
Amigo Mobility Intl., Inc.
Physical Medicine · 82d
Cleared Oct 25, 1999
FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
K992627 · ITI
Teftec Corp.
Physical Medicine · 81d
Cleared Oct 25, 1999
FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
K992628 · ITI
Teftec Corp.
Physical Medicine · 81d
Cleared Oct 25, 1999
STENTOR, PAGEVIEW
K992698 · LMD
Stentor, Inc.
Radiology · 75d
Cleared Oct 25, 1999
SELECT-SUTTER MICRO BIPOLAR FORCEPS
K992760 · GEI
Select Medizintechnik Hermann Sutter...
General & Plastic Surgery · 69d
Cleared Oct 25, 1999
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796 · HCA
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Oct 25, 1999
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90...
K992837 · KTW
Synthes (Usa)
Orthopedic · 63d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 25, 1999
AMBU HAND POWER SUCTION PUMP
K992902 · BSY
Ambu, Inc.
Anesthesiology · 56d
Cleared Oct 25, 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · HRX
Hydrocision, Inc.
Orthopedic · 48d
Cleared Oct 25, 1999
PICCOLO SODIUM TEST SYSTEM
K993211 · JGS
Abaxis, Inc.
Chemistry · 31d
Cleared Oct 25, 1999
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · LKJ
Diamedix Corp.
Immunology · 24d
Cleared Oct 25, 1999
INTELLISYSTEM II COLOR MONITOR
K993341 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 20d
Cleared Oct 25, 1999
K-ASSAY APO AI
K993345 · DER
Kamiya Biomedical Co.
Chemistry · 20d
Cleared Oct 22, 1999
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · CAW
Invacare Corp.
Anesthesiology · 372d
Cleared Oct 22, 1999
HTU3
K984313 · CBF
Hyox Systems , Ltd.
Anesthesiology · 324d
Cleared Oct 22, 1999
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K990637 · NEI
Synthes (Usa)
Dental · 238d
Cleared Oct 22, 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · DRB
Spectranetics Corp.
Cardiovascular · 232d
Cleared Oct 22, 1999
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · GXZ
Medtronic Xomed
Neurology · 226d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 22, 1999
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17
K992471 · BSO
Sims Portex, Inc.
Anesthesiology · 88d