Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
161809–161832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1982
ESTRADIOL KIT BY RIA
K820329 · CHP
Immuchem Corp.
Chemistry · 24d
Cleared Mar 04, 1982
T3 UPTAKE-SQUIBB DIAGNOSTIC KIT
K820340 · KHQ
E. R. Squibb & Sons, Inc.
Toxicology · 24d
Cleared Mar 04, 1982
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT
K820341 · CGR
E. R. Squibb & Sons, Inc.
Toxicology · 24d
Cleared Mar 04, 1982
PHYSIOLOGICAL PRESSURE TRANSDUCER #900
K820342 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 24d
Cleared Mar 04, 1982
CALI-LOOP
K820345 · LIB
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
CALI-PIPETTE
K820346 · LIB
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
ACCU-STAPH
K820347 · LHT
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 24d
Cleared Mar 04, 1982
ANALGESIA BREATHING CIRCUIT
K820352 · CAI
Cryogentics Northwest, Inc.
Anesthesiology · 24d
Cleared Mar 04, 1982
DISPOSABLE DIAPHRAGM DOMES
K820355 · DRS
Medex, Inc.
Cardiovascular · 24d
Cleared Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
K820360 · JJT
Aalto Scientific, Ltd.
Chemistry · 23d
Cleared Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392 · LAS
Ortho Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 04, 1982
UNIVERSAL TESTING & ANALYSIS SYSTEMS
K820414 · GWF
Lkc Technologies, Inc.
Neurology · 20d
Cleared Mar 04, 1982
#505 PORT. VITAL FUNCTIONS NEONATAL MON
K820416 · DRT
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Mar 04, 1982
#506 PORT. VITAL FUNCTIONS NEONATAL MON
K820417 · DRT
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Mar 04, 1982
P1808 MOBILE C-ARM IMAGE INTENSIFIER
K827087
Precise Optics
Radiology · 41d
Cleared Mar 04, 1982
RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC
K827125
Tecnomed, Inc.
Radiology · 28d
Cleared Mar 02, 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 147d
Cleared Mar 02, 1982
SSD-240 ULTRASONIC SCANNER
K813397 · IYO
U. S. A. Imaging Corp.
Radiology · 88d
Cleared Mar 02, 1982
CUTTERBOND ZINC PHOSPHATE CEMENT
K813532 · EMA
Cutter Laboratories, Inc.
Dental · 75d
Cleared Mar 02, 1982
UVEX MINI-SPECS
K813548 · HOI
Bacou USA, Inc. and Uvex Safety, Inc.
Ophthalmic · 71d
Cleared Mar 02, 1982
LUXOR PORCELAIN
K820057 · EIH
Jeneric Ind.
Dental · 50d
Cleared Mar 02, 1982
XENON DELIVERY SYSTEM
K820143 · IYT
Vital Signs, Inc.
Radiology · 42d
Cleared Mar 02, 1982
ALLTEK BROMPTON ENCODER
K820145 · DXK
Alltek Hospital Supplies , Ltd.
Cardiovascular · 42d
Cleared Mar 02, 1982
XOMED THERMAL MYRINGOTOMY SYSTEM
K820157 · HQP
Xomed, Inc.
Ophthalmic · 42d