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
151177–151200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1984
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN
K842374 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 91d
Cleared Sep 17, 1984
RICHARDS INTRA-ARTICULAR SHAVER MOTOR
K842475 · GEY
Richards Medical Co., Inc.
General & Plastic Surgery · 84d
Cleared Sep 17, 1984
ULTRASYSTEM LINSCAN PROBE
K842811 · IYO
Kelley Development Corp.
Radiology · 61d
Cleared Sep 17, 1984
BARD-PARKER FLAT/ROUND SILICONE DRAIN
K843006
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 48d
Cleared Sep 17, 1984
DISPOSABLE LINEAR CUTTER
K843034 · GDW
Ethicon, Inc.
General & Plastic Surgery · 47d
Cleared Sep 17, 1984
AUTOFLUOR IV SYSTEM
K843181 · DBM
Tech America Diagnostics
Immunology · 35d
Cleared Sep 17, 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · CGR
American Dade
Chemistry · 35d
Cleared Sep 17, 1984
FIAX 100 FLUOROMETER
K843356 · JZT
Intl. Diagnostic Technology
Immunology · 21d
Cleared Sep 14, 1984
ROTALEX LATEX AGGLUTINATION TEST
K841319 · LIQ
Orion Diagnostica, Inc.
Microbiology · 165d
Cleared Sep 14, 1984
PROLACTIN IRMA
K842478 · CFT
Euro-Diagnostics BV
Chemistry · 81d
Cleared Sep 14, 1984
NMS 1043 ENZYME IMMUNOASSAY KIT
K842499 · JHI
Nms Pharmaceuticals, Inc.
Immunology · 80d
Cleared Sep 14, 1984
MACBETH COLOR EIAD 100/100PC
K842770 · JJQ
Macbeth
Chemistry · 60d
Cleared Sep 14, 1984
DYNA-LYTE 2000
K842786 · CEM
Abbott Diagnostics
Chemistry · 115d
Cleared Sep 14, 1984
ACETIC ACID 1% V/V
K842938 · GGK
E K Ind., Inc.
Hematology · 51d
Cleared Sep 14, 1984
MICROBIOLOGICAL TRAY READER-MANUAL
K842947 · JJQ
American Micro Scan
Microbiology · 50d
Cleared Sep 14, 1984
CORITSOL PREMIX RIA KIT
K842957 · CGR
Biotecx Laboratories, Inc.
Chemistry · 49d
Cleared Sep 14, 1984
EMIT 700 OPIATE ASSAY
K843162 · DJG
Syva Co.
Toxicology · 35d
Cleared Sep 14, 1984
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174 · JFM
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
INORGANIC PHOSPHORUS TEST
K843177 · CEO
Sclavo, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
STREP SELECTIVE II
K843193 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
V AGAR SELECTIVE DEEPS
K843194 · JSI
Remel Co.
Microbiology · 31d
Cleared Sep 14, 1984
AMIKACIN CALIBRATOR ACA
K843210 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 30d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238 · LCX
Armkel, LLC
Chemistry · 23d
Cleared Sep 14, 1984
LIGHT BEAM COLLIMATOR
K843244 · IZW
Dealers X-Ray Co., Inc.
Radiology · 25d