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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125281–125304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1990
SARNS DELPHIN BASE ADAPTER WITH BATTERY
K902198 · KFM
3M Company
Cardiovascular · 58d
Cleared Jul 13, 1990
ARTALLOY (POWDER)
K902247 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY CAPS (PREDOSED CAPSULES)
K902248 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)
K902249 · EJJ
Degussa AG
Dental · 56d
Cleared Jul 13, 1990
EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
K902531 · EGW
G-C Intl. Corp.
Radiology · 38d
Cleared Jul 13, 1990
GSI 17 SCREENING AUDIOMETER
K902540 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 13, 1990
CARDIOMATIC MODEL MSC-1001
K902608 · DRT
Medical Systems Corp.
Cardiovascular · 31d
Cleared Jul 13, 1990
GYNESCOPE LAPAROSCOPES
K902655 · HET
Gynescope Corp.
Obstetrics & Gynecology · 28d
Cleared Jul 13, 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 17d
Cleared Jul 12, 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · FRN
Abbott Laboratories
General Hospital · 290d
Cleared Jul 12, 1990
CN GAURD, STERILE LATEX SURGICAL GLOVES
K896322 · FGO
C.N. Technocrats
Gastroenterology & Urology · 253d
Cleared Jul 12, 1990
LPI YAG MODEL 1003 SURGICAL LASER SYSTEM
K900837 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 140d
Cleared Jul 12, 1990
BAUMAN RIGID LARYNGOSCOPE
K901680 · CCW
Palex Intl. SA
Anesthesiology · 91d
Cleared Jul 12, 1990
PRESSURE TUBING AND ACCESSORIES
K901816 · CAH
Arbo Medical, Inc.
General Hospital · 80d
Cleared Jul 12, 1990
CUSTOMED LAP PACK I
K902029 · KKX
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
CUSTOMED LAP PACK III
K902030 · KKX
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
CUSTOMED LAP PACK IV
K902031 · KKX
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
SLT CONTACT LASER SYSTEMS (UROLOGY)
K902241 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 55d
Cleared Jul 12, 1990
TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY
K902264 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 52d
Cleared Jul 12, 1990
SURGICAL VIDEO CAMERA, MODEL 9500
K902359 · FWB
Seitz Technical Products, Inc.
General & Plastic Surgery · 44d
Cleared Jul 12, 1990
STERI-CATH(TM)
K902383 · BSY
Concord/Portex
Anesthesiology · 43d
Cleared Jul 11, 1990
CLAS PHOTOKERATOSCOPE
K895741 · HLQ
Kera-Metrics Corp.
Ophthalmic · 288d
Cleared Jul 11, 1990
COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
K896197 · KXK
Colab Intl., Inc.
Radiology · 257d
Cleared Jul 11, 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341 · LIF
Serim Research Corp.
Gastroenterology & Urology · 170d