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
148585–148608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1985
PREGNA-ZYME
K850992 · JHI
Armkel, LLC
Chemistry · 51d
Cleared May 01, 1985
I.V. START KIT
K851226
Perry, Div.
General & Plastic Surgery · 36d
Cleared May 01, 1985
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263 · HLI
American Medical Optics
Ophthalmic · 34d
Cleared May 01, 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264 · HLI
American Medical Optics
Ophthalmic · 34d
Cleared May 01, 1985
ABCO ISOLATION MASKS
K851312
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared May 01, 1985
ABCO SUTURE REMOVAL KITS-METAL & PLASTIC FORCEPS
K851313
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared May 01, 1985
ABCO DRAPES/TOWELS
K851314 · KKX
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 01, 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · FRG
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 01, 1985
EMIT 700 CANNABINOID 20 ASSAY
K851373 · LDJ
Syva Co.
Toxicology · 23d
Cleared May 01, 1985
76 EMA LINING CEMENT
K851468 · EMA
G-C Intl. Corp.
Dental · 15d
Cleared May 01, 1985
76 ELW BITE CHECKER SILICONE
K851469 · ELW
G-C Intl. Corp.
Dental · 15d
Cleared May 01, 1985
PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP
K851533 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 15d
Cleared May 01, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3150
K851534 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 15d
Cleared May 01, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3140
K851535 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 15d
Cleared May 01, 1985
PHILIPS UV-A SOLARIUM TYPE HP 3141
K851536 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 15d
Cleared Apr 30, 1985
ENTERNAL FEEDING PUMP BATTERY OPER.
K841104
Fresenius USA, Inc.
Gastroenterology & Urology · 412d
Cleared Apr 30, 1985
K-SOL
K844249 · LYX
Cilco, Inc.
Ophthalmic · 179d
Cleared Apr 30, 1985
ANGIOTEC SC 1221 SCAN CONVERTER
K850330 · LMA
Angiotec
Radiology · 92d
Cleared Apr 30, 1985
MEDIPART XENON BREATHING KIT MP-OIXM-I
K850366 · IYT
Medipart Jerry Alexander
Radiology · 90d
Cleared Apr 30, 1985
MEDIPART XENON BREATHING KIT MP-02XM-I
K850367 · IYT
Medipart Jerry Alexander
Radiology · 90d
Cleared Apr 30, 1985
FIAX TOXO-M ANTIBODIES TEST KIT
K850591 · GLZ
Intl. Diagnostic Technology
Microbiology · 75d
Cleared Apr 30, 1985
QUADRA TITER MICRO PLATES
K850725 · LIB
Microtech Medical Systems, Inc.
Microbiology · 67d
Cleared Apr 30, 1985
DEMAND OXYGEN SAUER DOS2 MODEL 10
K851235 · NFB
Applied Membrane Technology, Inc.
Anesthesiology · 35d
Cleared Apr 30, 1985
TDX ANALYZER W/NEPHELOMETRY CAROUSEL
K851253 · JQX
Abbott Laboratories
Chemistry · 33d