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
136489–136512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1988
UROSTHESIA
K880342 · FMF
Medical Research Innovators, Inc.
General Hospital · 30d
Cleared Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444 · DIF
Bio-Rad
Toxicology · 23d
Cleared Feb 25, 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602 · IMI
Mettler Electronics Corp.
Physical Medicine · 14d
Cleared Feb 24, 1988
IMAGEN INFLUENZA VIRUS A AND B TESTMI
K872958 · GNX
Boots-Celltech Diagnostics, Inc.
Microbiology · 210d
Cleared Feb 24, 1988
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
K873082 · GOD
Cambridge Bioscience Corp.
Microbiology · 203d
Cleared Feb 24, 1988
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
K873312 · GOD
Cambridge Bioscience Corp.
Microbiology · 190d
Cleared Feb 24, 1988
VIRGO(TM) MEASLES IGG ELISA
K873925 · LJB
Electro-Nucleonics Laboratories, Inc.
Microbiology · 152d
Cleared Feb 24, 1988
MEDITRON BI-2000 BIPOLAR GENERATOR W/IRRIGATION
K874798 · GEI
Xylog Corp.
General & Plastic Surgery · 93d
Cleared Feb 24, 1988
MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG
K874911 · HRX
Walter Lorenz Surgical, Inc.
Orthopedic · 84d
Cleared Feb 24, 1988
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · JPD
Bio-Rad
Hematology · 76d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · CHI
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CRSC)
K875191 · JFY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192 · JHY
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 24, 1988
BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
K875248 · JMT
Bioscan Instruments, Inc.
Chemistry · 64d
Cleared Feb 24, 1988
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
K880029 · KFH
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared Feb 24, 1988
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
K880039 · JJX
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · IPF
Chattanooga Group, Inc.
Physical Medicine · 35d
Cleared Feb 24, 1988
CARETEX SURGEON'S HOODS
K880431 · FXY
James River Corp.
General Hospital · 23d
Cleared Feb 24, 1988
CARETEX SURGEON'S CAPS
K880481 · FYF
James River Corp.
General & Plastic Surgery · 19d
Cleared Feb 24, 1988
CART, INSTRUMENT
K880536
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
CART, MULTIPURPOSE
K880539
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
LIGHT, SURGICAL, FLOOR STANDING
K880540 · FSS
Ferguson Medical
General & Plastic Surgery · 15d
Cleared Feb 24, 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · GCY
Baxter Healthcare Corp
General & Plastic Surgery · 7d
Cleared Feb 23, 1988
RIONET HEARING AID HB-75
K874510 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 113d