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
91417–91440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1997
THERMO-STAT SYSTEM
K970367 · DWJ
Aquarius Medical Corp.
Cardiovascular · 320d
Cleared Dec 17, 1997
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · MSS
Chiron Vision Corp.
Ophthalmic · 292d
Cleared Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · MML
Ipax, Inc.
Ophthalmic · 259d
Cleared Dec 17, 1997
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM)
K971790 · IYN
Urometrics, Inc.
Radiology · 217d
Cleared Dec 17, 1997
LACTEST I
K971944 · KHP
Jwt, Inc.
Chemistry · 204d
Cleared Dec 17, 1997
SUPERSKIN
K972081 · NEC
Medlogic Global Corp.
General & Plastic Surgery · 197d
Cleared Dec 17, 1997
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
K972192 · IYO
Perception, Inc.
Radiology · 190d
Cleared Dec 17, 1997
DENT-TEMP ACRYLIC
K972198 · EBG
Health-Dent Intl., Inc.
Dental · 189d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972633 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 156d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972634 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 156d
Cleared Dec 17, 1997
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
K972839 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S...
K972854 · FPA
Globe Ent., Inc.
General Hospital · 138d
Cleared Dec 17, 1997
PATHWAY ELECTROMYOGRAPH
K973537 · HCC
The Prometheus Group
Neurology · 90d
Cleared Dec 17, 1997
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS
K973540 · IYE
Elekta Oncology Systems, Inc.
Radiology · 90d
Cleared Dec 17, 1997
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594 · LYC
W.L. Gore & Associates, Inc.
Dental · 86d
Cleared Dec 17, 1997
VACUETTE MULTI-SAMPLE NEEDLE
K973620 · FMI
Greiner Meditech, Inc.
General Hospital · 85d
Cleared Dec 17, 1997
PRE-VIEW CHOLANGIOGRAPHY CLAMP
K973621 · GBZ
Nashville Surgical Instruments
General & Plastic Surgery · 85d
Cleared Dec 17, 1997
MINI FORCEPS WITH HF, 3.5MM
K973648 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 83d
Cleared Dec 17, 1997
VASOCOR PVR 100
K973659 · JOM
Vasocor, Inc.
Cardiovascular · 83d
Cleared Dec 17, 1997
DUODERM EXTRA THIN CGF DRESSING
K973716 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 17, 1997
COMBIDERM ACD
K973717 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 17, 1997
PILOT TUBE REPAIR KIT
K973755 · BSK
Instrumentation Industries, Inc.
Anesthesiology · 76d
Cleared Dec 17, 1997
DAPELLE HAIR REMOVER
K973773 · KCX
Wellquest Intl., Inc.
General & Plastic Surgery · 76d
Cleared Dec 17, 1997
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
K973793 · LMD
Olicon Imaging Systems, Inc.
Radiology · 72d