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
121369–121392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1991
NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS
K911227 · DTZ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared May 29, 1991
ADHESIVE PRECOATED BRACKETS
K911271 · DYH
Unitek Corp.
Dental · 68d
Cleared May 29, 1991
PALFIQUE ESTELITE
K911524 · EBF
Tokuyama America, Inc.
Dental · 54d
Cleared May 29, 1991
MEDTRACK TREADMILL
K911751 · IOL
Quinton, Inc.
Physical Medicine · 41d
Cleared May 28, 1991
ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
K901811 · BSP
Neuro Technology
Anesthesiology · 403d
Cleared May 28, 1991
SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT
K904165 · JXE
Occupational Preventive Diagnostics,...
Neurology · 259d
Cleared May 28, 1991
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · BTL
Ambu, Inc.
Anesthesiology · 209d
Cleared May 28, 1991
MX CYCLER
K905071 · EKX
Dakmed, Inc.
Dental · 200d
Cleared May 28, 1991
SATLITE PLUS PULSE OXIMETER
K905140 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 194d
Cleared May 28, 1991
MINIOX V PULSE OXIMETER
K905310 · DQA
Catalyst Research Corp.
Anesthesiology · 181d
Cleared May 28, 1991
L328 TRANSDUCER
K905456 · MAA
Acuson Corp.
Radiology · 175d
Cleared May 28, 1991
3M 6830 ELECTRODE
K905539 · GXY
3M Healthcare
Neurology · 168d
Cleared May 28, 1991
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
K910040 · BTM
Ambu, Inc.
Anesthesiology · 144d
Cleared May 28, 1991
FLOWPLUS AC330 PUMP GARMENTS
K910188 · JOW
Huntleigh Technology, Inc.
Cardiovascular · 132d
Cleared May 28, 1991
PHILIPS INTEGRIS V3000 AND V4000
K910370 · IZI
Philips Medical Systems, Inc.
Radiology · 119d
Cleared May 28, 1991
URAM OPHTHALMIC LASER ENDOSCOPE
K910532 · HQF
Martin S. Knopf Assoc., Inc.
Ophthalmic · 109d
Cleared May 28, 1991
AUTOCATH(TM) SET
K910876 · GBM
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared May 28, 1991
MOSS NASAL TUBE MARK IV
K910912 · KNT
Moss Medical Products
Gastroenterology & Urology · 84d
Cleared May 28, 1991
HSV-2 IGG ELISA TEST
K910952 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-2 IGM ELISA TEST
K910953 · LGC
Gull Laboratories, Inc.
Microbiology · 82d
Cleared May 28, 1991
HSV-1 IGG ELISA TEST
K910954 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
HSV-1 IGM ELISA TEST
K910955 · LGC
Gull Laboratories, Inc.
Microbiology · 83d
Cleared May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 77d
Cleared May 28, 1991
BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE
K911329 · FOC
C.R. Bard, Inc.
Gastroenterology & Urology · 63d