FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91249–91272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · LYY
Tillotson Healthcare Corp.
General Hospital · 71d
Cleared Jan 06, 1998
PHYSIO/1000
K974070 · FNM
Physio Designs, Inc.
General Hospital · 70d
Cleared Jan 06, 1998
V3 VALVE
K974145 · FPA
B.Braun Medical, Inc.
General Hospital · 64d
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · LTJ
Boehringer Mannheim Corp.
Immunology · 60d
Cleared Jan 06, 1998
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
K974296 · FNL
Invacare Corp.
General Hospital · 50d
Cleared Jan 06, 1998
APOLLO 9500
K974369 · EBZ
Ion Laser Technology
Dental · 47d
Cleared Jan 06, 1998
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568 · FQH
Chase Medical, Inc.
General Hospital · 32d
Cleared Jan 06, 1998
RANDOX IRON
K974604 · JMO
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
K974609 · JJX
Helena Laboratories
Chemistry · 27d
Cleared Jan 05, 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
K970648 · MSF
Renal Systems, Inc.
Gastroenterology & Urology · 319d
Cleared Jan 05, 1998
INCUWARMER
K971366 · FMT
Hill-Rom, Inc.
General Hospital · 266d
Cleared Jan 05, 1998
NPG + 2
K972971 · EJH
Aalba Dent, Inc.
Dental · 147d
Cleared Jan 05, 1998
DRG LARGE SCREW SYSTEM
K973810 · HWC
Dolphin Medical Technologies, Inc.
Orthopedic · 90d
Cleared Jan 05, 1998
PRIMA KTP LASER SYSTEM
K973828 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared Jan 05, 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · DQX
Cordis Corp.
Cardiovascular · 89d
Cleared Jan 05, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K973851 · FRN
Alexander Mfg. Co.
General Hospital · 89d
Cleared Jan 05, 1998
O BUTMENT HS IMPLANT
K973926 · DZE
"O" Co., Inc.
Dental · 82d
Cleared Jan 05, 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · EMA
Dentsply Intl.
Dental · 63d
Cleared Jan 05, 1998
PRE-POWDERED NITRILE EXAMINATION GLOVES
K974442 · LZY
P.T. Latexindo Tobaperkasa
Orthopedic · 41d
Cleared Jan 05, 1998
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
K974443 · LYZ
P.T. Latexindo Tobaperkasa
General Hospital · 41d
Cleared Jan 05, 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · KKX
Customed, Inc.
General Hospital · 24d
Cleared Jan 02, 1998
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
K970629 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 317d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304 · LFX
Inova Diagnostics, Inc.
Microbiology · 269d
Cleared Jan 02, 1998
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
K971653 · CGA
Clinical Diagnostics, Inc.
Chemistry · 241d