FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
134881–134904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1988
O.R. SARACAP
K881002 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 159d
Cleared Aug 15, 1988
RES-Q 1, 2, 3, 4 AND 5
K881207 · BTM
Nova-Ventrx
Anesthesiology · 147d
Cleared Aug 15, 1988
TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
K882022 · JAK
Philips Medical Systems, Inc.
Radiology · 94d
Cleared Aug 15, 1988
DIGITAL EMG MONITOR MYOTRON 120
K882266 · HCC
Ats Co.
Neurology · 76d
Cleared Aug 15, 1988
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
K882488 · LBR
Canyon Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 15, 1988
CT MAX 640 #B7940 JA/JE
K882581 · JAK
General Electric Co.
Radiology · 54d
Cleared Aug 15, 1988
FIXATION DEVICE, TRACH TUBE
K882694 · CBH
Bioseal
Anesthesiology · 49d
Cleared Aug 15, 1988
LUNG DIFFUSION GAS MIXTURE
K882817 · BYK
Swisco, Inc.
Anesthesiology · 38d
Cleared Aug 15, 1988
FASTIDIOUS INOCULUM BROTH
K883075 · JSD
Baxter Healthcare Corp
Microbiology · 33d
Cleared Aug 15, 1988
CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177
K883138 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 15, 1988
MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110
K883139 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 15, 1988
MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090
K883140 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 15, 1988
RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120
K883141 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 15, 1988
FETAL BOVINE SERUM, CAT. NO. 110-1120
K883285 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131
K883286 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
CALF SERUM, GAMMA IRRADIATED, CAT. NO. 110-1126
K883287 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR HORSE SERUM, HEAT INACTIVATED, #110-1113
K883288 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
CALF SERUM, HEAT INACTIVATED, CAT. # 110-1127
K883289 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR BOVINE SERUM, CAT. NO. 110-1116
K883290 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
DONOR HORSE SERUM, CAT. NO. 110-1110
K883291 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 15, 1988
BOVINE SERUM, CAT. LNO. 110-1115
K883292 · KIT
J R Scientific
Pathology · 11d
Cleared Aug 12, 1988
SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
K874544 · LGO
Molecular Biosystems, Inc.
Microbiology · 283d
Cleared Aug 12, 1988
BINAX EQUATE GLYCOHEMOGLOBIN
K874749 · LCP
Binax, Inc.
Hematology · 268d
Cleared Aug 12, 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · DXO
Ohmeda Medical
Cardiovascular · 164d