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
172729–172752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1977
INSTANT AIR
K771587 · BWC
Hyde, Vernon E., D.D.S.
Anesthesiology · 15d
Cleared Sep 02, 1977
API 20A
K771616 · JSP
Analytical Products, Inc.
Microbiology · 9d
Cleared Sep 02, 1977
SPECI-MIX
K771617 · GLE
Thermolyne Corp.
Hematology · 9d
Cleared Sep 02, 1977
PERMAGUM
K771627 · ELW
Espe GmbH (Us)
Dental · 7d
Cleared Aug 30, 1977
ICE BAND
K771002 · IME
Norcliff Thayer, Inc.
Physical Medicine · 89d
Cleared Aug 30, 1977
ANEROID SPHYGMOMETER
K771501 · DXQ
Swartz Medical Equipment
Cardiovascular · 25d
Cleared Aug 30, 1977
ANEROID SPHYGMOMETER
K771502
Swartz Medical Equipment
Cardiovascular · 25d
Cleared Aug 30, 1977
LAS-R RHEUMATOID FACTOR TEST
K771552 · DHR
Hyland Therapeutic Div., Travenol...
Microbiology · 18d
Cleared Aug 30, 1977
PATIENT MONITORS MODELS 78701A/78702A
K771572 · DRR
Hewlett-Packard Co.
Cardiovascular · 15d
Cleared Aug 30, 1977
MYERSONS SPEC. CROWN & BRIDGE RESIN
K771602 · EBG
Howmedica Corp.
Dental · 11d
Cleared Aug 30, 1977
AUDI-SIL EARMOLD MATERIAL
K771615 · ESH
Coe Laboratories, Inc.
Ear, Nose, Throat · 6d
Cleared Aug 26, 1977
CARDIOZYME CK-MB REAGENTS
K770974
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 87d
Cleared Aug 26, 1977
STEOILITY TESTING VESSEL
K771146 · JOJ
Tower Products, Inc.
General Hospital · 65d
Cleared Aug 26, 1977
HEAD FACILITATION VIBRATOR BK-5210
K771279 · IRO
Fred Sammons, Inc.
Physical Medicine · 74d
Cleared Aug 26, 1977
SMA II
K771336 · JJC
Technicon Instruments Corp.
Chemistry · 39d
Cleared Aug 26, 1977
SHELL VENEER
K771398 · ELM
L.D. Caulk Co.
Dental · 28d
Cleared Aug 26, 1977
LIP & CHEEK RETRACTOR
K771399 · EIG
L.D. Caulk Co.
Dental · 28d
Cleared Aug 26, 1977
NUVA-COTE (MODIFICATION TO)
K771402 · EBC
L.D. Caulk Co.
Dental · 28d
Cleared Aug 26, 1977
GUTTA GUN
K771406 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 28d
Cleared Aug 26, 1977
CANNULA CLAMP
K771419 · FKC
Quinton, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 26, 1977
TUBE OCCLUDING FORCEPS
K771424 · KOC
Quinton, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 26, 1977
INFUSION ACCELERATOR
K771458 · KZD
Terumo America, Inc.
General Hospital · 22d
Cleared Aug 26, 1977
AERO PULSE ALTERNATING PRES. PUMP
K771463 · FNM
Medline Industries, Inc.
General Hospital · 22d
Cleared Aug 26, 1977
STETHOSCOPE
K771504 · DQD
Swartz Medical Equipment
Cardiovascular · 21d