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
134017–134040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1988
LACTATE DEHYDROGENASE LDH
K883206 · CFJ
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Sep 09, 1988
PHASE II FSH KIT
K883279 · CGJ
Vitek Systems, Inc.
Chemistry · 37d
Cleared Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459 · JXM
Diagnostic Products Corp.
Toxicology · 28d
Cleared Sep 08, 1988
MYOCARD BIOPSY FORCEP
K881412 · DWZ
Fehling Medizintechnik GmbH
Cardiovascular · 157d
Cleared Sep 08, 1988
VAC-G (GUILLOTINE VITRECTOR)
K881519 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 150d
Cleared Sep 08, 1988
RADKOR SFC-21
K881701 · IYB
Radkor, Inc.
Radiology · 142d
Cleared Sep 08, 1988
TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM
K882015 · IYN
Ultramed, Inc.
Radiology · 118d
Cleared Sep 08, 1988
OLYMPUS REPLY CHEMISTRY ANALYZER
K882451 · JJE
Olympus Corp.
Chemistry · 86d
Cleared Sep 08, 1988
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
K882477 · JWY
Pasco Laboratories, Inc.
Microbiology · 86d
Cleared Sep 08, 1988
METATECH ROBINSON BOLT ACCESSORY
K882552 · GWM
Metatech Corp.
Neurology · 79d
Cleared Sep 08, 1988
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · IYN
Acuson Corp.
Radiology · 69d
Cleared Sep 08, 1988
TRACHEAL TUBE LASER SHIELD KIT
K883096 · BTR
Americal Corp.
Anesthesiology · 48d
Cleared Sep 08, 1988
CATAPULT BUCKY (KATAPULT BLENDA)
K883160 · KPR
Bay X-Ray, Inc.
Radiology · 44d
Cleared Sep 07, 1988
MICROLYTE 7
K880973 · JFP
The Rupp & Bowman Co.
Chemistry · 183d
Cleared Sep 07, 1988
VAC (OSCILLATING VITRECTOR)
K881520 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 149d
Cleared Sep 07, 1988
HEMATRAK(R) MODEL 590
K882579 · GKZ
Priority Service Systems
Hematology · 76d
Cleared Sep 07, 1988
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
K882612 · GKZ
Baker Instructions Corp.
Hematology · 75d
Cleared Sep 07, 1988
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST
K882998 · DCK
Amtec Diagnostics International, Inc.
Immunology · 51d
Cleared Sep 07, 1988
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
K883076 · JWY
Baxter Healthcare Corp
Microbiology · 56d
Cleared Sep 07, 1988
HISTONE REACTIVE ANA
K883232 · LLL
Val Tech Diagnostics, Inc.
Immunology · 37d
Cleared Sep 07, 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273 · DHB
3M Company
Immunology · 35d
Cleared Sep 07, 1988
QLIA IMMUNOCHEMISTRY SYSTEM
K883349 · JZT
Bd Becton Dickinson Vacutainer...
Immunology · 29d
Cleared Sep 07, 1988
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355 · DHR
United Biotech, Inc.
Immunology · 29d
Cleared Sep 07, 1988
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
K883385 · JXA
Los Alamos Diagnostics
Microbiology · 29d