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
138865–138888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1987
VITEL III, ECG TRANSMITTER
K872229 · DSH
Equimed Corp.
Cardiovascular · 50d
Cleared Jul 29, 1987
T.E.N.S. DEVICE MODEL SPL 2000
K872398 · GZJ
Spartan Laboratories, Inc.
Neurology · 37d
Cleared Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared Jul 28, 1987
LPM-1 (LASER POWER METER)
K871619 · GEX
Bio-Tek Instruments, Inc.
General & Plastic Surgery · 92d
Cleared Jul 28, 1987
FOCUS-GHB
K871679 · LCP
Awareness Technology, Inc.
Hematology · 90d
Cleared Jul 28, 1987
SOFSWAB
K871879 · EFW
Plastic Engineered Products Co.
Dental · 75d
Cleared Jul 28, 1987
WIDEX HEARING AID MODEL ES6
K872375 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805CD2
K872473 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805 SCD2
K872474 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 28, 1987
REM500 THREE WHEELED ELEC. CART.
K872518 · INI
Royal Enterprises Manufacturing, Inc.
Physical Medicine · 33d
Cleared Jul 28, 1987
FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
K872597 · DWO
Dianon Systems, Inc.
General & Plastic Surgery · 26d
Cleared Jul 28, 1987
OPSITE SPECIALITY DRAPES
K872757 · KKX
Smith & Nephew, Inc.
General Hospital · 15d
Cleared Jul 27, 1987
DIABETES RISK DETECTOR
K864544 · JIL
Pearce Clinical Laboratories, Inc.
Chemistry · 250d
Cleared Jul 27, 1987
OVUQUICK SELF-TEST (OVUQUICK
K871726 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 83d
Cleared Jul 27, 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Jul 27, 1987
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · HQC
CooperVision, Inc.
Ophthalmic · 75d
Cleared Jul 27, 1987
IV ADMINISTRATION SET
K871908 · BRZ
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
K872320 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
FRIGITRONICS ACC-1000 CAPSULE CUTTER
K872362 · HQC
Frigitronics of Connecticut, Inc.
Ophthalmic · 39d
Cleared Jul 27, 1987
T.E.N.S. DEVICE MODEL SPL 2000S
K872399 · GZJ
Spartan Laboratories, Inc.
Neurology · 35d
Cleared Jul 27, 1987
FH LEN
K872503 · HQY
Fu Heng First Industrial Co., Ltd.
Ophthalmic · 33d
Cleared Jul 27, 1987
MELANITE I
K872506 · HQG
Aura Lens Products
Ophthalmic · 33d
Cleared Jul 27, 1987
FORTEC MI-306, MI-327 DIGITAL THERMOMETER
K872584 · FLL
Nam Tai , Ltd.
General Hospital · 26d