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
161857–161880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1981
HEPAFIX BIOPSY NEEDLE SET
K813085 · KNW
Burron Medical Products, Inc.
Gastroenterology & Urology · 18d
Cleared Nov 20, 1981
CEMENT RING
K813089 · JDI
Biomet, Inc.
Orthopedic · 18d
Cleared Nov 20, 1981
RICHARDS ACETABULAR BRUSH
K813093 · HTR
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 18d
Cleared Nov 20, 1981
ACETABULAR CEMENT COMPRESSOR
K813094
Richard'S Medical Equip., Inc.
Orthopedic · 17d
Cleared Nov 20, 1981
TENS DEVICE
K813098
Staodynamics, Inc.
Neurology · 17d
Cleared Nov 20, 1981
POWER DRIVE WHEELCR
K813104 · ITI
Intl. Medical Equipment Corp.
Physical Medicine · 17d
Cleared Nov 20, 1981
KEYMED KEY LIGHT
K813133 · HET
Keymed, Inc.
Obstetrics & Gynecology · 15d
Cleared Nov 17, 1981
PENTAX FLEXIBLE DRIODENOFIBERSCOPE
K812810 · FAK
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 42d
Cleared Nov 17, 1981
ROBINSON CATHETERS NON-STERILE
K812887 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 17, 1981
ESTILUX POSTERIOR
K812889 · EBF
Kulzer, Inc.
Dental · 33d
Cleared Nov 17, 1981
GUIDE WIRE
K813026 · OCY
Inmed Corp.
Gastroenterology & Urology · 20d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · EXB
Howmedica Corp.
Gastroenterology & Urology · 15d
Cleared Nov 16, 1981
EXTRASENSR ULTRAFILTRATION MONITOR
K811972 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 129d
Cleared Nov 16, 1981
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
K812111 · DYG
Bionomy, Inc.
Cardiovascular · 112d
Cleared Nov 16, 1981
DIGICLOT 2-#820
K812121 · JPA
Volu Sol Medical Industries
Hematology · 112d
Cleared Nov 16, 1981
ULTRA COM
K812209 · DXK
Ultranamics, Inc.
Cardiovascular · 104d
Cleared Nov 16, 1981
MODEL 900S INTRAOCULAR PROBE
K812219 · HQF
Lumenis, Inc.
Ophthalmic · 102d
Cleared Nov 16, 1981
VARIABLE FOCUS 3.5 MHZ TRANSDUCER
K812301 · ITX
Adr Ultrasound
Radiology · 94d
Cleared Nov 16, 1981
PDS* ABSORBABLE LIGATING CLIPS
K812323 · FZP
Ethicon, Inc.
General & Plastic Surgery · 91d
Cleared Nov 16, 1981
VTS-1000 VISUAL TESTING SYSTEM
K812331 · HLX
Nicolet Biomedical Instruments
Ophthalmic · 90d
Cleared Nov 16, 1981
SURGICAL PAWS
K812388 · GDJ
Berkeley Medevices
General & Plastic Surgery · 88d
Cleared Nov 16, 1981
SURGICAL LOOPS
K812389 · GAD
Berkeley Medevices
General & Plastic Surgery · 88d
Cleared Nov 16, 1981
SYNTHEMED PULSE GENERATOR VVI MODEL 1000
K812464 · DXY
Synthemed Corp.
Cardiovascular · 77d
Cleared Nov 16, 1981
DISPOSABLE SUTURE REMOVAL SCISSORS
K812555 · JOK
Medcare Products
General Hospital · 69d