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
134281–134304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1988
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
K883048 · LDZ
Alpha-Tec Systems, Inc.
Pathology · 32d
Cleared Aug 17, 1988
ATS PARA-SET IODINE ALCOHOL SOLUTION
K883049 · JTS
Alpha-Tec Systems, Inc.
Pathology · 29d
Cleared Aug 17, 1988
ATS PARA-SET CARBOL-XYLENE SOLUTION
K883061 · JTS
Alpha-Tech Systems, Inc.
Pathology · 29d
Cleared Aug 16, 1988
STAR CALC
K875027 · BZC
Infrasonics Corp.
Anesthesiology · 253d
Cleared Aug 16, 1988
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
K882223 · KDQ
Deknatel, Inc.
General Hospital · 82d
Cleared Aug 16, 1988
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
K882229 · IOQ
Biologics Intl., Inc.
Physical Medicine · 88d
Cleared Aug 16, 1988
NONREBREATHING CIRCUIT
K882285 · BTM
Dryden Corp.
Anesthesiology · 76d
Cleared Aug 16, 1988
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
K882930 · CCW
Pilling Co.
Anesthesiology · 34d
Cleared Aug 16, 1988
L-F/KODAK FLEXIBLE GRID CASSETTE
K883312 · IXA
Mallinckrodt Group, Inc.
Radiology · 11d
Cleared Aug 15, 1988
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K880525 · IZO
Fischer Imaging Corp.
Radiology · 188d
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