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
106297–106320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1994
LORDEX LUMBAR EXTENSION MACHINE
K930735 · ISD
Lordex, Inc.
Physical Medicine · 595d
Cleared Sep 29, 1994
FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
K930915 · MLY
Gebauer Co.
Physical Medicine · 583d
Cleared Sep 29, 1994
OHMEDA HAND HELD OXIMETER
K931304 · DQA
Ohmeda Medical
Anesthesiology · 563d
Cleared Sep 29, 1994
SONOQUICK ULTRASOUND GEL
K931908 · IYO
Sonomed Technology, Inc.
Radiology · 531d
Cleared Sep 29, 1994
CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL
K931909 · IYO
Sonomed Technology, Inc.
Radiology · 531d
Cleared Sep 29, 1994
SIEMENS FLUID DELIVERY SYSTEM, MMT-9500
K933545 · FRN
Siemens Infusions Systems
General Hospital · 436d
Cleared Sep 29, 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · KNT
Cook Urological, Inc.
Gastroenterology & Urology · 419d
Cleared Sep 29, 1994
MASTER ALERT
K934848 · FIP
Master Hydro Systems, Inc.
Gastroenterology & Urology · 343d
Cleared Sep 29, 1994
PODIATRIC MATERIAL
K940132 · MNE
Crown Delta Corp.
Physical Medicine · 269d
Cleared Sep 29, 1994
CARDIOVASCULAR MEASUREMENT SYSTEM-CMS
K940172 · IZI
Medis Medical Imaging Systems, Inc.
Radiology · 261d
Cleared Sep 29, 1994
ULTIMA UNIPOLAR MODULAR HEAD
K940190 · KWL
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 259d
Cleared Sep 29, 1994
AL-3300
K940997 · HLM
Hoya Corp. USA
Ophthalmic · 209d
Cleared Sep 29, 1994
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · DZE
Biomet, Inc.
Dental · 178d
Cleared Sep 29, 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
K941620 · DZE
Biomet, Inc.
Dental · 178d
Cleared Sep 29, 1994
LORENZ SURGICAL FINNED DENTAL IMPLANT
K941621 · DZE
Biomet, Inc.
Dental · 178d
Cleared Sep 29, 1994
XPERT NCT
K941865 · HKX
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 164d
Cleared Sep 29, 1994
BETA C COUNTER
K943072 · KPT
Capintec Instruments, Inc.
Radiology · 93d
Cleared Sep 29, 1994
FAMILY FITNESS SHIATSU MASSAGER
K943092 · ISA
Conair Corp.
Physical Medicine · 93d
Cleared Sep 29, 1994
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · FPB
Gelman Sciences, Inc.
General Hospital · 92d
Cleared Sep 29, 1994
STATLOCK CV
K943147 · KMK
Venetec, Inc.
General Hospital · 91d
Cleared Sep 29, 1994
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · LHI
B. Braun of America, Inc.
General Hospital · 90d
Cleared Sep 29, 1994
FUTURA JUNIOR 300/310
K943262 · FPO
Merivaara Instrumentarium Corp.
General Hospital · 84d
Cleared Sep 29, 1994
OHIO CARE PLUS INCUBATOR
K943360 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared Sep 29, 1994
GENEMED YAG 1000 MEDICAL LASER
K943479 · GEX
Genemed, Inc.
General & Plastic Surgery · 72d