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
157129–157152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200
K823586 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Apr 06, 1983
EXTENSION HANDLE FOR ACUTOME PROBE
K830037 · HQE
Precision Medical Instruments, Inc.
Ophthalmic · 89d
Cleared Apr 06, 1983
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · ELW
Wallace A. Erickson & Co.
Dental · 89d
Cleared Apr 06, 1983
FLORET OPHTHALMIC EYE SPEAR
K830262 · HOZ
Ritmed, Inc.
Ophthalmic · 71d
Cleared Apr 06, 1983
REPLAM HYDROXYAPATITE
K830304 · LYC
Replam Corp.
Dental · 68d
Cleared Apr 06, 1983
ESOPHAGEAL PROBE W/TEMP. INDICATOR
K830353 · FLL
Science Development Corp.
General Hospital · 62d
Cleared Apr 06, 1983
PROVIDONE-IODINE SWABSTICKS
K830393 · GEC
H & P Industries, Inc.
General & Plastic Surgery · 58d
Cleared Apr 06, 1983
PROVIDONE-IODINE PREP-PADS & TOWELETTES
K830394 · GEC
H & P Industries, Inc.
General & Plastic Surgery · 58d
Cleared Apr 06, 1983
SYN-02 PN AMPLIFIER
K830421 · FFX
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 06, 1983
TEMP TRACE
K830530 · FLL
Progress Mankind Technology
General Hospital · 47d
Cleared Apr 06, 1983
DENTAL PORCELAIN POWDER
K830553 · EIH
Dentsply Intl.
Dental · 42d
Cleared Apr 06, 1983
ENSURE DRESSING
K830593 · NAD
Warner-Lambert Co.
General & Plastic Surgery · 41d
Cleared Apr 06, 1983
COBE RX METER
K830629 · FLB
Cobe Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 06, 1983
URIC ACID COLORIMETRIC DETERMINATION
K830679 · KNK
Dow Instruments & Reagents, Inc.
Chemistry · 33d
Cleared Apr 06, 1983
TDX THYROXINE
K830683 · KLI
Abbott Laboratories
Chemistry · 33d
Cleared Apr 06, 1983
MMH PTH RIA KIT
K830700 · CEW
Diagnostic Systems
Chemistry · 30d
Cleared Apr 06, 1983
TOTAL BILIRUBIN REAGENT
K830714 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared Apr 06, 1983
KEMTEK 102
K830751 · JJJ
Kemble Instruments, Inc.
Chemistry · 27d
Cleared Apr 06, 1983
BINOCULAR MAGNIFIER 2X
K830774 · HKC
Almore Intl., Inc.
Ophthalmic · 26d
Cleared Apr 06, 1983
ELECTRIC MOUTH MIRROR
K830777 · EAX
Almore Intl., Inc.
Dental · 26d
Cleared Apr 06, 1983
POINT, PAPER ENDODONTIC
K830814 · KJJ
Endodent, Inc.
Dental · 22d
Cleared Apr 06, 1983
MODIFICATION ELECTRONIC CLINICAL THERMO-
K830819 · FLL
Mon-A-Therm, Inc.
General Hospital · 22d
Cleared Apr 06, 1983
EYE DRAPE
K830822 · HMT
CooperVision, Inc.
General Hospital · 22d
Cleared Apr 06, 1983
STERILE 5 IN 1 CONNECTORS
K830835 · GAZ
Abco Dealers, Inc.
General Hospital · 21d