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
142153–142176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1986
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · JIL
Behring Diagnostics, Inc.
Chemistry · 183d
Cleared Oct 03, 1986
BEHRING RAPIMAT II
K861263 · JJQ
Behring Diagnostics, Inc.
Chemistry · 182d
Cleared Oct 03, 1986
XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15
K861688 · GEX
Xanar, Inc.
General & Plastic Surgery · 154d
Cleared Oct 03, 1986
VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
K861698 · JAK
Visiscan
Radiology · 151d
Cleared Oct 03, 1986
MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG
K862090 · FPD
Kendall Mcgaw Laboratories, Inc.
Gastroenterology & Urology · 123d
Cleared Oct 03, 1986
CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)
K862645 · IYE
Varian Assoc., Inc.
Radiology · 84d
Cleared Oct 03, 1986
ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K862669 · GFD
U. S. Diagnostics, Inc.
General & Plastic Surgery · 81d
Cleared Oct 03, 1986
TANDEM SUCTION CAUTERY
K862753 · GEI
Celebration Designs, Inc.
General & Plastic Surgery · 73d
Cleared Oct 03, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036 · DHB
Pharmacia, Inc.
Immunology · 52d
Cleared Oct 03, 1986
OHMEDA AUXILIARY POWER SYSTEM
K863208 · FMT
Ohmeda Medical
General Hospital · 45d
Cleared Oct 03, 1986
LACTATE DEHYDROGENASE(LD) PROCEDURE
K863255 · CFJ
Data Medical Associates, Inc.
Chemistry · 39d
Cleared Oct 03, 1986
MODIFIED FOLEY CATHETER
K863302 · KOD
Sheridan Catheter Corp.
Gastroenterology & Urology · 39d
Cleared Oct 03, 1986
HEMOLYSE
K863503 · GGK
Reagent Laboratory, Inc.
Hematology · 24d
Cleared Oct 03, 1986
MODIFIED MEDI-QUET TOURNIQUET, MODEL #2740-00
K863551
Depuy, Inc.
General & Plastic Surgery · 21d
Cleared Oct 03, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586 · JPZ
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
CREATINE PHOSPHOKINASE(CK) PROCEDURE
K863587 · CGS
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
K863604
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Oct 03, 1986
ARTHROSCOPIC IRRIGATION PUMP
K863605 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Oct 03, 1986
TDX(R) AMYLASE II
K863622 · JFJ
Abbott Laboratories
Chemistry · 17d
Cleared Oct 03, 1986
PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5
K863671 · KNX
Samco Industries, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 03, 1986
CORNING ELISA PLATES
K863789 · LIB
Corning Medical & Scientific
Chemistry · 7d
Cleared Oct 02, 1986
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)
K860831 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 211d
Cleared Oct 02, 1986
T-FASTENER
K861599 · KNT
Medi-Tech, Inc.
Gastroenterology & Urology · 156d
Cleared Oct 02, 1986
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862422 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d