FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87193–87216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1999
PERFUSOR COMPACT
K983005 · FRN
B.Braun Medical, Inc.
General Hospital · 160d
Cleared Feb 04, 1999
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K983614 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 113d
Cleared Feb 04, 1999
CORE-IDE
K984037 · EBD
Roydent Dental Products, Inc.
Dental · 84d
Cleared Feb 04, 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053 · JXG
Medtronic PS Medical
Neurology · 90d
Cleared Feb 04, 1999
OSTEO-MESH TM-300
K984230 · JEY
Osteogenics Biomedical, Inc.
Dental · 71d
Cleared Feb 04, 1999
DORNIER MEDILAS R
K984349 · GEX
Dornier
General & Plastic Surgery · 62d
Cleared Feb 04, 1999
MIRACLE MIX POWDER/LIQUID
K984505 · EMA
GC America, Inc.
Dental · 48d
Cleared Feb 04, 1999
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
K984561 · FPA
Msr, Inc.
General Hospital · 43d
Cleared Feb 04, 1999
CANDELA GENTLELASE II DERMATOLOGICAL LASER
K984601 · GEX
Candela Corp.
General & Plastic Surgery · 38d
Cleared Feb 04, 1999
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND...
K984613 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND...
K984616 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
CLEARFIL SE BOND
K990040 · KLE
Kuraray Co.
Dental · 29d
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · MEH
Exactech, Inc.
Orthopedic · 15d
Cleared Feb 03, 1999
NUMOBAG
K981949 · KPJ
Numotech, Inc.
General & Plastic Surgery · 245d
Cleared Feb 03, 1999
OPTICOAT T4 EIA KIT
K982298 · KLI
Biotecx Laboratories, Inc.
Chemistry · 217d
Cleared Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · DQX
Radi Medical Systems AB
Cardiovascular · 119d
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 119d
Cleared Feb 03, 1999
ENDOPATH ULTRA VERESS NEEDLE
K983925 · HIF
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 03, 1999
CERALAS DIODE LASER SYSTEM (MODEL H)
K983950 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Feb 03, 1999
EDI VERIS SYSTEM
K983983 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 86d
Cleared Feb 03, 1999
PANORAMIC200 OPTHALMOSCOPE
K983999 · HLI
Optos Plc.
Ophthalmic · 86d
Cleared Feb 03, 1999
ABBOTT ARCHITECT B12
K984108 · LIG
Abbott Laboratories
Chemistry · 78d
Cleared Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL...
K984209 · HWC
Biomet, Inc.
Orthopedic · 71d
Cleared Feb 03, 1999
ADVANCED REVISION PRODUCT LINE EXTENSION
K990030 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d